Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-25 @ 6:31 AM
Study NCT ID:
NCT03735420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-27
First Post:
2018-10-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Xanthohumol Metabolism and Signature
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C104536', 'term': 'xanthohumol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbradley@nunm.edu', 'phone': '5035521862', 'title': 'Ryan Bradley, ND, MPH', 'organization': 'National University of Natural Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'Mild/Grade 1: No intervention; asymptomatic lab or radiographic findings; marginal clinical significance Moderate/Grade 2: OTC or single-physician visit; AE limited activities of daily living for \\<48hrs Severe/Grade 3: AE significantly limited basic self-care but did not require initial hospitalization or prolongation of hospitalization; Not immediately life-threatening but disabling Serious/Grade 4: Life threatening Serious/Grade 5: Death', 'eventGroups': [{'id': 'EG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Allergy symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Dry eyes and periorbital twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Increased thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Shortness of breath on exertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Peripheral edema/swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Itchy/dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Breast swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Decreased urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}, {'term': 'General body pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAEv4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Plasma Inflammatory Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'OG001', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}], 'classes': [{'title': 'Week 2: Interleukin 1-beta (IL-1b)', 'categories': [{'measurements': [{'value': '220', 'spread': '358', 'groupId': 'OG000'}, {'value': '-2463', 'spread': '12960', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: IL-1b', 'categories': [{'measurements': [{'value': '172', 'spread': '677', 'groupId': 'OG000'}, {'value': '-3153', 'spread': '12490', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: IL-1b', 'categories': [{'measurements': [{'value': '2368', 'spread': '7689', 'groupId': 'OG000'}, {'value': '-620', 'spread': '16359', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: IL-1b', 'categories': [{'measurements': [{'value': '-133', 'spread': '328', 'groupId': 'OG000'}, {'value': '-3624', 'spread': '12306', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Interleukin 6 (IL-6)', 'categories': [{'measurements': [{'value': '-54', 'spread': '252', 'groupId': 'OG000'}, {'value': '-784', 'spread': '2795', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: IL-6', 'categories': [{'measurements': [{'value': '-79', 'spread': '263', 'groupId': 'OG000'}, {'value': '-684', 'spread': '2552', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: IL-6', 'categories': [{'measurements': [{'value': '-51', 'spread': '251', 'groupId': 'OG000'}, {'value': '-764', 'spread': '2802', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: IL-6', 'categories': [{'measurements': [{'value': '3565', 'spread': '12594', 'groupId': 'OG000'}, {'value': '-784', 'spread': '2792', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Interleukin 8 (IL-8)', 'categories': [{'measurements': [{'value': '1796', 'spread': '6380', 'groupId': 'OG000'}, {'value': '-5914', 'spread': '22847', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: IL-8', 'categories': [{'measurements': [{'value': '-7', 'spread': '352', 'groupId': 'OG000'}, {'value': '7669', 'spread': '62489', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: IL-8', 'categories': [{'measurements': [{'value': '276', 'spread': '840', 'groupId': 'OG000'}, {'value': '-6955', 'spread': '25976', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: IL-8', 'categories': [{'measurements': [{'value': '2639', 'spread': '6116', 'groupId': 'OG000'}, {'value': '-6882', 'spread': '25878', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Interleukin 10 (IL-10)', 'categories': [{'measurements': [{'value': '76', 'spread': '273', 'groupId': 'OG000'}, {'value': '-46', 'spread': '180', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: IL-10', 'categories': [{'measurements': [{'value': '10', 'spread': '44', 'groupId': 'OG000'}, {'value': '-34', 'spread': '150', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: IL-10', 'categories': [{'measurements': [{'value': '-2', 'spread': '17', 'groupId': 'OG000'}, {'value': '-49', 'spread': '177', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: IL-10', 'categories': [{'measurements': [{'value': '-3', 'spread': '13', 'groupId': 'OG000'}, {'value': '-43', 'spread': '171', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Interleukin 12p70 (IL-12p70)', 'categories': [{'measurements': [{'value': '2', 'spread': '9', 'groupId': 'OG000'}, {'value': '25', 'spread': '154', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: IL-12p70', 'categories': [{'measurements': [{'value': '3', 'spread': '12', 'groupId': 'OG000'}, {'value': '-7', 'spread': '52', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: IL-12p70', 'categories': [{'measurements': [{'value': '-2', 'spread': '12', 'groupId': 'OG000'}, {'value': '-14', 'spread': '46', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: IL-12p70', 'categories': [{'measurements': [{'value': '1', 'spread': '9', 'groupId': 'OG000'}, {'value': '0', 'spread': '55', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Tumor Necrosis Factor Alpha (TNFa)', 'categories': [{'measurements': [{'value': '2', 'spread': '9', 'groupId': 'OG000'}, {'value': '-8', 'spread': '124', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: TNFa', 'categories': [{'measurements': [{'value': '-3', 'spread': '9', 'groupId': 'OG000'}, {'value': '-28', 'spread': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: TNFa', 'categories': [{'measurements': [{'value': '-4', 'spread': '10', 'groupId': 'OG000'}, {'value': '-23', 'spread': '102', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: TNFa', 'categories': [{'measurements': [{'value': '-1', 'spread': '8', 'groupId': 'OG000'}, {'value': '-25', 'spread': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Circulating pro-inflammatory cytokine concentrations (tumor necrosis factor (TNF)-α, interleukin (IL)-1 beta, IL-6, IL-8, IL-10, and IL-12p70), will be measured simultaneously with a flow cytometry-based multiplex assay. The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Intervention-attributable Adverse Events [Safety and Tolerability]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'classes': [{'title': 'Week 2 Grade 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Grade 1', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Grade 1', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Grade 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events (Grade 1); New onset "moderate" adverse events (Grade 2). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported.', 'unitOfMeasure': 'Adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'classes': [{'title': 'Urinary 6-Prenylnaringenin (6-PN): Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 6-PN: Week 2', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 6-PN: Week 4', 'categories': [{'measurements': [{'value': '.591', 'spread': '2.132', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 6-PN: Week 6', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 6-PN: Week 8', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 8-Prenylnaringenin (8-PN): Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 8-PN: Week 2', 'categories': [{'measurements': [{'value': '6.811', 'spread': '12.029', 'groupId': 'OG000'}, {'value': '1.412', 'spread': '3.877', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 8-PN: Week 4', 'categories': [{'measurements': [{'value': '6.588', 'spread': '0.840', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 8-PN: Week 6', 'categories': [{'measurements': [{'value': '7.196', 'spread': '14.662', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary 8- PN Week 8', 'categories': [{'measurements': [{'value': '4.725', 'spread': '7.769', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Dihydroxanthohumol (DXN): Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '.086', 'spread': '.312', 'groupId': 'OG001'}]}]}, {'title': 'Urinary DXN: Week 2', 'categories': [{'measurements': [{'value': '.562', 'spread': '.542', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary DXN: Week 4', 'categories': [{'measurements': [{'value': '.561', 'spread': '.522', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary DXN: Week 6', 'categories': [{'measurements': [{'value': '.410', 'spread': '.325', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary DXN: Week 8', 'categories': [{'measurements': [{'value': '2.043', 'spread': '4.702', 'groupId': 'OG000'}, {'value': '.016', 'spread': '.059', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Desmethyldihydroxanthohumol (DDXN): Baseline', 'categories': [{'measurements': [{'value': '.042', 'spread': '.152', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary DDXN: Week 2', 'categories': [{'measurements': [{'value': '.041', 'spread': '.148', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary DDXN: Week 4', 'categories': [{'measurements': [{'value': '.036', 'spread': '.131', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary DDXN: Week 6', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary DDXN: Week 8', 'categories': [{'measurements': [{'value': '.071', 'spread': '.257', 'groupId': 'OG000'}, {'value': '.023', 'spread': '.083', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Isoxanthohumol (IXN): Baseline', 'categories': [{'measurements': [{'value': '2.237', 'spread': '4.364', 'groupId': 'OG000'}, {'value': '.299', 'spread': '1.080', 'groupId': 'OG001'}]}]}, {'title': 'Urinary IXN: Week 2', 'categories': [{'measurements': [{'value': '94.120', 'spread': '82.500', 'groupId': 'OG000'}, {'value': '2.121', 'spread': '4.001', 'groupId': 'OG001'}]}]}, {'title': 'Urinary IXN: Week 4', 'categories': [{'measurements': [{'value': '103.920', 'spread': '75.201', 'groupId': 'OG000'}, {'value': '.494', 'spread': '1.782', 'groupId': 'OG001'}]}]}, {'title': 'Urinary IXN: Week 6', 'categories': [{'measurements': [{'value': '66.628', 'spread': '41.899', 'groupId': 'OG000'}, {'value': '.281', 'spread': '1.012', 'groupId': 'OG001'}]}]}, {'title': 'Urinary IXN: Week 8', 'categories': [{'measurements': [{'value': '95.756', 'spread': '83.275', 'groupId': 'OG000'}, {'value': '.484', 'spread': '1.745', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Xanthohumol (XN) Baseline', 'categories': [{'measurements': [{'value': '1.952', 'spread': '13.967', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary XN: Week 2', 'categories': [{'measurements': [{'value': '21.280', 'spread': '12.112', 'groupId': 'OG000'}, {'value': '4.666', 'spread': '16.440', 'groupId': 'OG001'}]}]}, {'title': 'Urinary XN: Week 4', 'categories': [{'measurements': [{'value': '14.908', 'spread': '8.667', 'groupId': 'OG000'}, {'value': '.124', 'spread': '.448', 'groupId': 'OG001'}]}]}, {'title': 'Urinary XN: Week 6', 'categories': [{'measurements': [{'value': '19.979', 'spread': '12.242', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary XN: Week 8', 'categories': [{'measurements': [{'value': '19.952', 'spread': '13.967', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 6-Prenylnaringenin (6PN): Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 6-PN: Week 2', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 6-PN: Week 4', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 6-PN: Week 6', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 6-PN: Week 8', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 8-Prenylnaringenin: Baseline', 'categories': [{'measurements': [{'value': '1.302', 'spread': '3.034', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 8-PN: Week 2', 'categories': [{'measurements': [{'value': '1.503', 'spread': '3.340', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 8-PN: Week 4', 'categories': [{'measurements': [{'value': '.840', 'spread': '3.144', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 8-PN: Week 6', 'categories': [{'measurements': [{'value': '1.001', 'spread': '2.563', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma 8-PN: Week 8', 'categories': [{'measurements': [{'value': '1.302', 'spread': '3.034', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Dihydroxanthohumol (DXN): Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma DXN: Week 2', 'categories': [{'measurements': [{'value': '.968', 'spread': '3.622', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma DXN: Week 4', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma DXN: Week 6', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '7.288', 'spread': '25.245', 'groupId': 'OG001'}]}]}, {'title': 'Plasma DXN: Week 8', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Desmethyldihydroxanthohumol (DDXN): Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma DDXN: Week 2', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma DDXN: Week 4', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma DDXN: Week 6', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma DDXN: Week 8', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Isoxanthohumol (IXN): Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '.275', 'spread': '.992', 'groupId': 'OG001'}]}]}, {'title': 'Plasma IXN: Week 2', 'categories': [{'measurements': [{'value': '7.864', 'spread': '4.135', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma IXN: Week 4', 'categories': [{'measurements': [{'value': '6.999', 'spread': '3.514', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma IXN: Week 6', 'categories': [{'measurements': [{'value': '6.140', 'spread': '3.565', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma IXN: Week 8', 'categories': [{'measurements': [{'value': '8.174', 'spread': '3.794', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Xanthohumol (XN): Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '.365', 'spread': '.974', 'groupId': 'OG001'}]}]}, {'title': 'Plasma XN: Week 2', 'categories': [{'measurements': [{'value': '7.156', 'spread': '3.888', 'groupId': 'OG000'}, {'value': '1.325', 'spread': '3.424', 'groupId': 'OG001'}]}]}, {'title': 'Plasma XN: Week 4', 'categories': [{'measurements': [{'value': '6.784', 'spread': '3.497', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Plasma XN: Week 6', 'categories': [{'measurements': [{'value': '5.810', 'spread': '3.153', 'groupId': 'OG000'}, {'value': '.822', 'spread': '2.304', 'groupId': 'OG001'}]}]}, {'title': 'Plasma XN: Week 8', 'categories': [{'measurements': [{'value': '5.796', 'spread': '3.188', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma.', 'unitOfMeasure': 'nanograms per millileter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Levels of Metabolic Byproducts of Xanthohumol: Stool', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma. As stool metabolites have not yet been analyzed, data will be released upon assessment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Bile Acids', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Bile acid concentrations in blood and feces, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry, and expressed as mean change over time from baseline.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Gut Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '35.2', 'spread': '76.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '12.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '13.4', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '12.7', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '15.2', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Fecal calprotectin, a protein associated with gut inflammation and irritable gut syndrome, will be measured by enzyme-linked immunosorbent assay, and expressed as mean change over time from baseline.', 'unitOfMeasure': 'microgram per milligram (ug/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '22.9', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '18.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '21.1', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '18.4', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.', 'unitOfMeasure': 'milligrams per deciliter (mgdL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '18.0', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '16.1', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '3.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '16.4', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '5.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '15.1', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '2.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.', 'unitOfMeasure': 'milligrams per decileter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gamma-Glutamyl Transferase (GGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '12.1', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '12.3', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '5.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '12.9', 'spread': '4.74', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '6.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '12.1', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '5.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks', 'description': 'Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.', 'unitOfMeasure': 'milligrams per decileter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Glomerular Filtration Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '108.7', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '112.0', 'spread': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '110.6', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '111.8', 'spread': '12.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '109.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '111.4', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '108.4', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '111.8', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks', 'description': 'Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as mean change from baseline.', 'unitOfMeasure': 'millileters per minute (mL/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Urea Nitrogen to Creatinine Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'OG001', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.6', 'spread': '40.8', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '25.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '16.4', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '32.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '15.2', 'spread': '31.5', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '26.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '14.8', 'spread': '41.4', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '23.4', 'groupId': 'OG001'}]}]}, {'title': 'Closeout', 'categories': [{'measurements': [{'value': '14.5', 'spread': '30.9', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '26.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Blood urea nitrogen (BUN) : creatinine (Cr) is a ratio of serum concentrations of two compounds associated with renal function. Reported as mean change from baseline.', 'unitOfMeasure': 'Ratio of BUN (mg/dL) to Cr (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complete Blood Count Abnormals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'classes': [{'title': 'Total Red Blood Cell Count (Week 4): number of abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total Red Blood Cell Count (Week 4) : number of new abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total Red Blood Cell Count (Week 8) : number of abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total Red Blood Cell Count (Week 8) : number of new abnormals', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mean Corpuscular Hemoglobin (Week 8) : number of abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mean Corpuscular Hemoglobin (Week 8) : number of new abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 2) : number of abnormals', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 2) : number of new abnormals', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 4) : number of abnormals', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 4) : number of new abnormals', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 6) : number of abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 6) : number of new abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 8) : number of abnormals', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 8) : %new abnormals', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 2) : number of abnormals', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 2) : number of new abnormals', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 4) : number of abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 4) : number of new abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 6) : number of abnormals', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 6) : number of new abnormals', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 8) : number of abnormal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 8) : %new abnormals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of the various subtypes of blood cells (i.e., red blood cells, white blood cells, and platelets), plus indices including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), and hematocrit. Reported as: % abnormal (i.e., number of participants with an abnormal value compared to the number of participants in the group) and % new abnormals if abnormal counts were noted. Abnormality is assessed according to standards for age and sex measurements under Quest Diagnostics criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Red Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'OG001', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}], 'classes': [{'title': 'Total Red Blood Cell Count (Week 2)', 'categories': [{'measurements': [{'value': '.08', 'spread': '.22', 'groupId': 'OG000'}, {'value': '.04', 'spread': '.15', 'groupId': 'OG001'}]}]}, {'title': 'Total Red Blood Cell Count (Week 4)', 'categories': [{'measurements': [{'value': '-.06', 'spread': '.20', 'groupId': 'OG000'}, {'value': '.04', 'spread': '.20', 'groupId': 'OG001'}]}]}, {'title': 'Total Red Blood Cell Count (Week 6)', 'categories': [{'measurements': [{'value': '-.04', 'spread': '.16', 'groupId': 'OG000'}, {'value': '.07', 'spread': '.23', 'groupId': 'OG001'}]}]}, {'title': 'Total Red Blood Cell Count (Week 8)', 'categories': [{'measurements': [{'value': '.00', 'spread': '.23', 'groupId': 'OG000'}, {'value': '.08', 'spread': '.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of total red blood cell count. Reported as mean change from baseline.', 'unitOfMeasure': 'mean change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total White Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'OG001', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}], 'classes': [{'title': 'Total White Blood Cell Count (Week 2)', 'categories': [{'measurements': [{'value': '-.05', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-.59', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 4)', 'categories': [{'measurements': [{'value': '-.05', 'spread': '.98', 'groupId': 'OG000'}, {'value': '-.09', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 6)', 'categories': [{'measurements': [{'value': '.23', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '-.24', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Total White Blood Cell Count (Week 8)', 'categories': [{'measurements': [{'value': '.21', 'spread': '.76', 'groupId': 'OG000'}, {'value': '-.24', 'spread': '1.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of total white blood cell count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.', 'unitOfMeasure': 'thousand cells per microliter (1000/uL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'OG001', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}], 'classes': [{'title': 'Platelet Count (Week 2)', 'categories': [{'measurements': [{'value': '3.54', 'spread': '24.05', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '26.04', 'groupId': 'OG001'}]}]}, {'title': 'Platelet Count (Week 4)', 'categories': [{'measurements': [{'value': '3.46', 'spread': '19.62', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '19.86', 'groupId': 'OG001'}]}]}, {'title': 'Platelet Count (Week 6)', 'categories': [{'measurements': [{'value': '14.00', 'spread': '32.01', 'groupId': 'OG000'}, {'value': '22.93', 'spread': '41.90', 'groupId': 'OG001'}]}]}, {'title': 'Platelet Count (Week 8)', 'categories': [{'measurements': [{'value': '10.46', 'spread': '25.62', 'groupId': 'OG000'}, {'value': '7.14', 'spread': '20.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of platelet count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.', 'unitOfMeasure': 'thousand cells per microliter (1000/uL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Corpuscular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'OG001', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}], 'classes': [{'title': 'Mean Corpuscular Volume (Week 2)', 'categories': [{'measurements': [{'value': '.14', 'spread': '.76', 'groupId': 'OG000'}, {'value': '.20', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Mean Corpuscular Volume (Week 4)', 'categories': [{'measurements': [{'value': '.61', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Mean Corpuscular Volume (Week 6)', 'categories': [{'measurements': [{'value': '.04', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Mean Corpuscular Volume (Week 8)', 'categories': [{'measurements': [{'value': '.04', 'spread': '.80', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '1.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of mean corpuscular volume (MCV). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.', 'unitOfMeasure': 'femtoliter (fL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Corpuscular Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'OG001', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}], 'classes': [{'title': 'Mean Corpuscular Hemoglobin (Week 2)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Mean Corpuscular Hemoglobin (Week 4)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Mean Corpuscular Hemoglobin (Week 6)', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Mean Corpuscular Hemoglobin (Week 8)', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of mean corpuscular hemoglobin (MCH). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.', 'unitOfMeasure': 'picograms (pg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'OG001', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}], 'classes': [{'title': 'Hematocrit (Week 2)', 'categories': [{'measurements': [{'value': '0.77', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (Week 4)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (Week 6)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (Week 8)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '2.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of hematocrit. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.', 'unitOfMeasure': 'percent (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'FG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.\n\nXanthohumol: The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.'}, {'id': 'BG001', 'title': 'Placebo Oral Capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.\n\nPlacebo oral capsule: The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.06', 'spread': '6.45', 'groupId': 'BG000'}, {'value': '33.14', 'spread': '5.36', 'groupId': 'BG001'}, {'value': '30.97', 'spread': '6.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '23.41', 'spread': '2.23', 'groupId': 'BG000'}, {'value': '23.30', 'spread': '2.57', 'groupId': 'BG001'}, {'value': '23.36', 'spread': '2.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per meters-squared (kg/m2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate', 'classes': [{'categories': [{'measurements': [{'value': '64.50', 'spread': '11.78', 'groupId': 'BG000'}, {'value': '61.07', 'spread': '8.30', 'groupId': 'BG001'}, {'value': '62.90', 'spread': '10.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '69.82', 'spread': '10.33', 'groupId': 'BG000'}, {'value': '70.60', 'spread': '14.59', 'groupId': 'BG001'}, {'value': '70.18', 'spread': '12.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.73', 'spread': '0.12', 'groupId': 'BG000'}, {'value': '1.73', 'spread': '0.11', 'groupId': 'BG001'}, {'value': '1.73', 'spread': '0.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-01', 'size': 338652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-16T12:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Randomization will occur in up to 8 blocks of 4 based on biological sex. Initial randomization series will be generated using readily available random sequence generators designed to do so. A series of sequential envelopes will be generated, each containing the allocation for one participant. Envelopes will be opaque and signed across the seal. The randomization "code" will be kept in a sealed envelope with a signature across the label and dated the day of creation. Study product and comparator (placebo) will be compounded and placed in identical opaque capsules outside the institution.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to receive either encapsulated xanthohumol in a rice protein vehicle, or an identical capsule containing vehicle alone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-02', 'studyFirstSubmitDate': '2018-10-11', 'resultsFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-10', 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plasma Inflammatory Markers', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Circulating pro-inflammatory cytokine concentrations (tumor necrosis factor (TNF)-α, interleukin (IL)-1 beta, IL-6, IL-8, IL-10, and IL-12p70), will be measured simultaneously with a flow cytometry-based multiplex assay. The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported'}, {'measure': 'Incidence of Intervention-attributable Adverse Events [Safety and Tolerability]', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events (Grade 1); New onset "moderate" adverse events (Grade 2). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported.'}], 'secondaryOutcomes': [{'measure': 'Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma.'}, {'measure': 'Change in Levels of Metabolic Byproducts of Xanthohumol: Stool', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN). The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma. As stool metabolites have not yet been analyzed, data will be released upon assessment.'}, {'measure': 'Bile Acids', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Bile acid concentrations in blood and feces, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry, and expressed as mean change over time from baseline.'}, {'measure': 'Gut Inflammation', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Fecal calprotectin, a protein associated with gut inflammation and irritable gut syndrome, will be measured by enzyme-linked immunosorbent assay, and expressed as mean change over time from baseline.'}, {'measure': 'Aspartate Aminotransferase (AST)', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.'}, {'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.'}, {'measure': 'Gamma-Glutamyl Transferase (GGT)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks', 'description': 'Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.'}, {'measure': 'Estimated Glomerular Filtration Rate', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks', 'description': 'Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as mean change from baseline.'}, {'measure': 'Blood Urea Nitrogen to Creatinine Ratio', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Blood urea nitrogen (BUN) : creatinine (Cr) is a ratio of serum concentrations of two compounds associated with renal function. Reported as mean change from baseline.'}, {'measure': 'Complete Blood Count Abnormals', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of the various subtypes of blood cells (i.e., red blood cells, white blood cells, and platelets), plus indices including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), and hematocrit. Reported as: % abnormal (i.e., number of participants with an abnormal value compared to the number of participants in the group) and % new abnormals if abnormal counts were noted. Abnormality is assessed according to standards for age and sex measurements under Quest Diagnostics criteria.'}, {'measure': 'Total Red Blood Cell Count', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of total red blood cell count. Reported as mean change from baseline.'}, {'measure': 'Total White Blood Cell Count', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of total white blood cell count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.'}, {'measure': 'Platelet Count', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of platelet count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.'}, {'measure': 'Mean Corpuscular Volume', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of mean corpuscular volume (MCV). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.'}, {'measure': 'Mean Corpuscular Hemoglobin', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of mean corpuscular hemoglobin (MCH). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.'}, {'measure': 'Hematocrit', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, and 8 weeks.', 'description': 'Enumeration of hematocrit. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['xanthohumol', 'gut microbiome', 'inflammation'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38358253', 'type': 'DERIVED', 'citation': 'Jamieson PE, Smart EB, Bouranis JA, Choi J, Danczak RE, Wong CP, Paraiso IL, Maier CS, Ho E, Sharpton TJ, Metz TO, Bradley R, Stevens JF. Gut enterotype-dependent modulation of gut microbiota and their metabolism in response to xanthohumol supplementation in healthy adults. Gut Microbes. 2024 Jan-Dec;16(1):2315633. doi: 10.1080/19490976.2024.2315633. Epub 2024 Feb 15.'}, {'pmid': '33028396', 'type': 'DERIVED', 'citation': 'Bradley R, Langley BO, Ryan JJ, Phipps J, Hanes DA, Stack E, Jansson JK, Metz TO, Stevens JF. Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial. Trials. 2020 Oct 7;21(1):835. doi: 10.1186/s13063-020-04769-2.'}]}, 'descriptionModule': {'briefSummary': 'A pilot study to assess the safety and tolerability of oral xanthohumol in humans, to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature.', 'detailedDescription': 'This is a double-masked, placebo controlled, randomized clinical trial of xanthohumol, which is a constituent of hops (Humulus lupulus). Hops and its constituents have a long history of use for a variety of conditions. However, knowledge is limited regarding the measurable biological markers of human exposure, and the role of xanthohumol metabolism by microorganisms present in the gut. This information is necessary for the development of xanthohumol as a potential therapeutic intervention in conditions such as inflammatory bowel disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women aged 21-50 years\n* Willing to take isolated xanthohumol as a dietary supplement for 8 weeks\n* Willing to have blood drawn semi-weekly and to fast for 10-12 hours before blood draws\n* Willing and able to collect semi-weekly stool samples at home\n* Able to speak, read, and understand English\n* Must be able to provide written informed consent\n* Non-smokers (including tobacco and Cannabis products, combusted or vaporized)\n\nExclusion Criteria:\n\n* History of any chronic disease including, but not limited to: diabetes (type 1 or 2); uncontrolled hypertension; coronary artery disease resulting in angina; cardiovascular disease requiring percutaneous coronary intervention (PCI), bypass, or past myocardial infarction or stroke; blood disease including current anemia; cancer (except non-melanoma skin cancer) within the last year or still requiring chemotherapy or hormonal therapy; chronic kidney disease; liver disease including viral hepatitis, non-alcoholic fatty liver disease, or alcoholic hepatitis/cirrhosis; any immunocompromising condition including human immunodeficiency virus/acquired immunodeficiency syndrome or organ transplant requiring anti-rejection medications; chronic osteoarthritis requiring joint replacement or daily use of NSAIDs; chronic endocrine condition including but not limited to: Cushing\'s, Addison\'s, Hashimoto\'s thyroiditis, Grave\'s disease, etc.\n* Body Mass Index (BMI) less than 20 (underweight) or greater than 30 (obese)\n* Consumption of more than 1 microbrew beer per day\n* Use of NSAIDs more than once per week for headaches, routine aches/pains, etc.\n* Use of any prescription drugs, including oral contraceptives (due to potential interference with mechanisms under investigation)\n* Use of prescription opioids for any reason within the past 3 months\n* Use of prescription corticosteroids for any reason within the past 3 months\n* Free of acute viral or bacterial infection, or recent infection within the last 14 days or still requiring prescription medication for treatment\n* Free of recent acute trauma occurring within the last 14 days\n* Currently or recently (within last 14 days) taking any dietary supplements containing xanthohumol flavonoids, or other known herbal "anti-inflammatories" including: curcumin, turmeric, fenugreek, hops, rosemary, ginger, white willow, Devil\'s claw, fish oil (doses\\>1 g/day), or quercetin. Candidates will be given the option to "wash out" for 14 days and re-contact the study team.\n* Currently receiving intravenous nutrition support therapy (or within the last 30 days)\n* Currently taking anti-coagulant or anti-platelet prescription medications (or they were taken within the last 30 days)\n* Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within the last 30 days)\n* Initiation of or changes to supplements or medications within 30 days prior to screening\n* Initiation of or changes to an exercise regimen within 30 days prior to screening\n* Initiation of or changes to a food plan within 30 days prior to screening\n* Current involvement or within 30 days prior to screening of a significant diet or weight loss program, such as NutriSystem, Jenny Craig, Atkin\'s or other low-carb diet programs, or very low-calorie liquid diet programs (such as optifast, medifast, and/or HMR)\n* Hospitalization (for any reason other than an elective medical procedure) within 3 months prior to screening\n* Gastrointestinal surgery within 3 months prior to screening\n* Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis).\n* Engaging in vigorous exercise more than 6 hours per week.\n* Women who are lactating, pregnant or planning pregnancy within the next four months\n* Typical intake of more than 2 alcohol-containing beverages per day, more than 14 per week, or more than 4 in any single day within the past 28 days\n* Use of recreational drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 30 days of screening\n* Currently participating in another interventional research study or participated in another interventional study within 30 days of screening'}, 'identificationModule': {'nctId': 'NCT03735420', 'acronym': 'XMaS', 'briefTitle': 'Xanthohumol Metabolism and Signature', 'organization': {'class': 'OTHER', 'fullName': 'National University of Natural Medicine'}, 'officialTitle': 'Xanthohumol Metabolism and Signature (XMaS) in Healthy Adults', 'orgStudyIdInfo': {'id': 'RB9718'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xanthohumol', 'description': 'Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.', 'interventionNames': ['Drug: Xanthohumol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo oral capsule', 'description': 'Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Xanthohumol', 'type': 'DRUG', 'description': 'The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.', 'armGroupLabels': ['Xanthohumol']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.', 'armGroupLabels': ['Placebo oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Helfgott Research Institute National University of Natural Medicine', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Ryan Bradley, ND, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Natural Medicine'}]}, 'ipdSharingStatementModule': {'timeFrame': 'We will share our data no later than on acceptance of the first publication of the findings from the respective data set(s).', 'ipdSharing': 'YES', 'description': 'We will use the University of California San Diego (UCSD) Metabolomics Workbench for sharing metabolomics datasets and results (including raw data matrices, platform information, and associated metadata).\n\nFor activity-based proteomics data, we will use PRIDE or the MassIVE data repository at UCSD.\n\nNucleic acid sequence data will be submitted to the National Center for Biotechnology Information (NCBI) Short Read Archive.\n\nGene expression data will be submitted to Gene expression Omnibus at NCBI. Microbiome metadata will be deposited into database of Genotypes and Phenotypes.\n\nMetagenomic nucleic acid sequence data will additionally be deposited in Metagenomic Rapid Annotations using Subsystems Technology (MG-RAST) at Argonne National Laboratory, along with associated metadata.\n\nMicrobiome summary files (e.g., tables cataloging: sample metadata, taxon or protein family abundances across samples) publicly available through github.', 'accessCriteria': 'All indicated repositories are freely available to the research community.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Natural Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon State University', 'class': 'OTHER'}, {'name': 'Pacific Northwest National Laboratory', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Helfgott Research Institute', 'investigatorFullName': 'Ryan Bradley', 'investigatorAffiliation': 'National University of Natural Medicine'}}}}