Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT03413735
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2018-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D019446', 'term': 'Endotoxemia'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bruno.27@osu.edu', 'phone': '614-292-5522', 'title': 'Dr. Richard Bruno', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'Consumption of the formulated green tea extract did not put any of the participants at risk for serious adverse events, not did it put any participants at risk for all-cause omrtality.', 'eventGroups': [{'id': 'EG000', 'title': 'Lean - Placebo', 'description': 'Lean Participants consumed a placebo confection for 1-month', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Obese - Placebo', 'description': 'Obese Participants consumed a placebo confection for 1-month', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lean - GTE', 'description': 'Lean Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) for 1-month', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Obese - GTE', 'description': 'Obese Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) for 1-month', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Endotoxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed gelatin extract with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed gelatin extract with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.44', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '12.97', 'spread': '6.44', 'groupId': 'OG001'}, {'value': '12.25', 'spread': '6.05', 'groupId': 'OG002'}, {'value': '17.65', 'spread': '12.58', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 - Fasting', 'description': 'Serum endotoxin concentration', 'unitOfMeasure': 'EU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Endotoxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed gelatin extract with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed gelatin extract with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.59', 'spread': '7.38', 'groupId': 'OG000'}, {'value': '12.38', 'spread': '7.53', 'groupId': 'OG001'}, {'value': '13.00', 'spread': '5.44', 'groupId': 'OG002'}, {'value': '15.62', 'spread': '5.32', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2 - Fasting', 'description': 'Serum endotoxin concentration', 'unitOfMeasure': 'EU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Endotoxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed gelatin extract with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed gelatin extract with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.33', 'spread': '4.55', 'groupId': 'OG000'}, {'value': '16.46', 'spread': '4.91', 'groupId': 'OG001'}, {'value': '11.33', 'spread': '5.56', 'groupId': 'OG002'}, {'value': '15.45', 'spread': '6.94', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 - Fasting', 'description': 'Serum endotoxin concentration', 'unitOfMeasure': 'EU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gut Permeability - Lactulose to Mannitol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection that did not contain green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection that did not contain green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.03', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 - 0-5 hours', 'description': 'Urinary Lactulose/Mannitol Ratio (mg/mg)', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gut Permeability - Lactulose to Mannitol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.14', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 - 6-24 hours', 'description': 'Urinary Lactulose/Mannitol Ratio (mg/mg)', 'unitOfMeasure': 'Urinary Lactulose/Mannitol Ratio (mg/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gut Permeability - Lactulose to Mannitol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '0.12', 'spread': '0.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 - 0-5 hours', 'description': 'Urinary Lactulose/Mannitol Ratio (mg/mg)', 'unitOfMeasure': 'Urinary Lactulose/Mannitol Ratio (mg/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gut Permeability - Lactulose to Mannitol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.21', 'spread': '0.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 - 6-24 hours', 'description': 'Urinary Lactulose/Mannitol Ratio (mg/mg)', 'unitOfMeasure': 'Urinary Lactulose/Mannitol Ratio (mg/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gut Permeability - Sucralose to Erythritol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 - 6-24 hours', 'description': 'Urinary Sucralose/Erythritol Ratio (mg/mg)', 'unitOfMeasure': 'Urinary Sucralose/Erythritol (mg/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gut Permeability - Sucralose to Erythritol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.004', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.004', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 - 0-24 hours', 'description': 'Urinary Sucralose/Erythritol Ratio (mg/mg)', 'unitOfMeasure': 'Urinary Sucralose/Erythritol (mg/m', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urinary Sucralose/Erythritol Ratio (mg/mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 - 6-24 hours', 'description': 'Ratio of excretion of urinary sugars (Sucralose to Erythritol)', 'unitOfMeasure': 'Urinary Sucralose/Erythritol (mg/m', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gut Permeability - Sucralose to Erythritol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 - 0-24 hours', 'description': 'Urinary Sucralose/Erythritol Ratio (mg/mg)', 'unitOfMeasure': 'Urinary Sucralose/Erythritol (mg/m', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Firmicutes to Bacteroidetes Ratio - Microbiota', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.34', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '2.32', 'groupId': 'OG001'}, {'value': '21.51', 'spread': '31.65', 'groupId': 'OG002'}, {'value': '9.36', 'spread': '7.48', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)', 'unitOfMeasure': '% of abundance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Firmicutes to Bacteroidetes Ratio - Microbiota', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.90', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '8.95', 'spread': '15.13', 'groupId': 'OG001'}, {'value': '4.69', 'spread': '4.17', 'groupId': 'OG002'}, {'value': '9.32', 'spread': '3.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bioavailability - Epigallocatechin Gallate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.46', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection', 'description': 'Area under the curve (AUC) of plasma epigallocatechin calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin gallate is measured in umol/L over time (hours) resulting in the AUC.', 'unitOfMeasure': 'umol/L x h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Bioavailability - Epigallocatechin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection', 'description': 'Area under the curve (AUC) of plasma epigallocatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin is measured in umol/L over time (hours) resulting in the AUC.', 'unitOfMeasure': 'umol/L x h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Bioavailability - Epicatechin Gallate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection', 'description': 'Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechins is measured in umol/L over time (hours) resulting in the AUC.', 'unitOfMeasure': 'umol/L x h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Bioavailability - Epicatechin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection', 'description': 'Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechin is measured in umol/L over time (hours) resulting in the AUC.', 'unitOfMeasure': 'umol/L x h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Cmax of Epigallocatechin Gallate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Cmax of Epigallocatechin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Cmax of Epicatechin Gallate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Cmax of Epicatechin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Tmax of Epigallocatechin Gallate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.32', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Tmax of Epigallocatechin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.92', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Tmax of Epicatechin Gallate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.05', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Tmax of Epicatechin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.66', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.'}, {'type': 'SECONDARY', 'title': 'Calprotectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.99', 'spread': '79.07', 'groupId': 'OG000'}, {'value': '27.54', 'spread': '20.58', 'groupId': 'OG001'}, {'value': '32.01', 'spread': '25.52', 'groupId': 'OG002'}, {'value': '62.62', 'spread': '90.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Fecal calprotectin concentration', 'unitOfMeasure': 'ug/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Calprotectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG001', 'title': 'Obese - GTE', 'description': 'Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).'}, {'id': 'OG002', 'title': 'Lean - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}, {'id': 'OG003', 'title': 'Obese - Placebo', 'description': 'Participants consumed a gelatin confection with no green tea extract.'}], 'classes': [{'categories': [{'measurements': [{'value': '249.62', 'spread': '590.21', 'groupId': 'OG000'}, {'value': '25.74', 'spread': '13.94', 'groupId': 'OG001'}, {'value': '36.20', 'spread': '24.15', 'groupId': 'OG002'}, {'value': '73.04', 'spread': '103.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Fecal calprotectin concentration', 'unitOfMeasure': 'ug/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lean - Placebo', 'description': 'Confection without green tea extract consumed daily for 4 weeks\n\nPlacebo: Confections containing no green tea extract that will be ingested daily for 4 weeks'}, {'id': 'FG001', 'title': 'Lean - GTE', 'description': 'Confection with green tea extract consumed daily for 4 weeks\n\nGreen Tea Extract: Confections containing green tea extract that will be ingested daily for 4 weeks'}, {'id': 'FG002', 'title': 'Obese - Placebo', 'description': 'Confection without green tea extract consumed daily for 4 weeks\n\nPlacebo: Confections containing no green tea extract that will be ingested daily for 4 weeks'}, {'id': 'FG003', 'title': 'Obese - GTE', 'description': 'Confection with green tea extract consumed daily for 4 weeks\n\nGreen Tea Extract: Confections containing green tea extract that will be ingested daily for 4 weeks'}], 'periods': [{'title': 'Pharmacokinetic Study', 'milestones': [{'type': 'STARTED', 'comment': 'All participants in this arm received a single dose of GTE in Phase 1. This arm label reflects phenotype and randomized group assignment for Phase 2 only.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Randomized Controlled Trial', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In Phase 1, participants were stratified by phenotype (lean vs. obese) and received a single dose of a green tea extract (GTE)-enriched confection. This phase was conducted to evaluate catechin bioavailability. All participants consumed the same GTE confection. After a washout period, participants were randomized in Phase 2 to receive either a GTE or placebo confection daily for 4 weeks in a double-blind trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Confection', 'description': 'Confection without green tea extract consumed daily for 4 weeks\n\nPlacebo: Confections containing no green tea extract that will be ingested daily for 4 weeks'}, {'id': 'BG001', 'title': 'Green Tea Extract-Confection', 'description': 'Confection with green tea extract consumed daily for 4 weeks\n\nGreen Tea Extract: Confections containing green tea extract that will be ingested daily for 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.', 'spread': '6.48', 'groupId': 'BG000'}, {'value': '28.35', 'spread': '9.04', 'groupId': 'BG001'}, {'value': '28.175', 'spread': '7.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-22', 'size': 336731, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-27T13:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2018-01-22', 'resultsFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endotoxin', 'timeFrame': 'Week 0 - Fasting', 'description': 'Serum endotoxin concentration'}, {'measure': 'Endotoxin', 'timeFrame': 'Week 2 - Fasting', 'description': 'Serum endotoxin concentration'}, {'measure': 'Endotoxin', 'timeFrame': 'Week 4 - Fasting', 'description': 'Serum endotoxin concentration'}], 'secondaryOutcomes': [{'measure': 'Gut Permeability - Lactulose to Mannitol Ratio', 'timeFrame': 'Week 0 - 0-5 hours', 'description': 'Urinary Lactulose/Mannitol Ratio (mg/mg)'}, {'measure': 'Gut Permeability - Lactulose to Mannitol Ratio', 'timeFrame': 'Week 0 - 6-24 hours', 'description': 'Urinary Lactulose/Mannitol Ratio (mg/mg)'}, {'measure': 'Gut Permeability - Lactulose to Mannitol Ratio', 'timeFrame': 'Week 4 - 0-5 hours', 'description': 'Urinary Lactulose/Mannitol Ratio (mg/mg)'}, {'measure': 'Gut Permeability - Lactulose to Mannitol Ratio', 'timeFrame': 'Week 4 - 6-24 hours', 'description': 'Urinary Lactulose/Mannitol Ratio (mg/mg)'}, {'measure': 'Gut Permeability - Sucralose to Erythritol Ratio', 'timeFrame': 'Week 0 - 6-24 hours', 'description': 'Urinary Sucralose/Erythritol Ratio (mg/mg)'}, {'measure': 'Gut Permeability - Sucralose to Erythritol Ratio', 'timeFrame': 'Week 0 - 0-24 hours', 'description': 'Urinary Sucralose/Erythritol Ratio (mg/mg)'}, {'measure': 'Urinary Sucralose/Erythritol Ratio (mg/mg)', 'timeFrame': 'Week 4 - 6-24 hours', 'description': 'Ratio of excretion of urinary sugars (Sucralose to Erythritol)'}, {'measure': 'Gut Permeability - Sucralose to Erythritol Ratio', 'timeFrame': 'Week 4 - 0-24 hours', 'description': 'Urinary Sucralose/Erythritol Ratio (mg/mg)'}, {'measure': 'Firmicutes to Bacteroidetes Ratio - Microbiota', 'timeFrame': 'Week 0', 'description': 'Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)'}, {'measure': 'Firmicutes to Bacteroidetes Ratio - Microbiota', 'timeFrame': 'Week 4', 'description': 'Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)'}, {'measure': 'Bioavailability - Epigallocatechin Gallate', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection', 'description': 'Area under the curve (AUC) of plasma epigallocatechin calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin gallate is measured in umol/L over time (hours) resulting in the AUC.'}, {'measure': 'Bioavailability - Epigallocatechin', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection', 'description': 'Area under the curve (AUC) of plasma epigallocatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin is measured in umol/L over time (hours) resulting in the AUC.'}, {'measure': 'Bioavailability - Epicatechin Gallate', 'timeFrame': 'Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection', 'description': 'Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechins is measured in umol/L over time (hours) resulting in the AUC.'}, {'measure': 'Bioavailability - Epicatechin', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection', 'description': 'Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechin is measured in umol/L over time (hours) resulting in the AUC.'}, {'measure': 'Cmax of Epigallocatechin Gallate', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection'}, {'measure': 'Cmax of Epigallocatechin', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection'}, {'measure': 'Cmax of Epicatechin Gallate', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection'}, {'measure': 'Cmax of Epicatechin', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection'}, {'measure': 'Tmax of Epigallocatechin Gallate', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection'}, {'measure': 'Tmax of Epigallocatechin', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection'}, {'measure': 'Tmax of Epicatechin Gallate', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection'}, {'measure': 'Tmax of Epicatechin', 'timeFrame': 'Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection', 'description': 'Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection'}, {'measure': 'Calprotectin', 'timeFrame': 'Week 0', 'description': 'Fecal calprotectin concentration'}, {'measure': 'Calprotectin', 'timeFrame': 'Week 4', 'description': 'Fecal calprotectin concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Endotoxemia', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '28038359', 'type': 'BACKGROUND', 'citation': 'Li J, Sapper TN, Mah E, Moller MV, Kim JB, Chitchumroonchokchai C, McDonald JD, Bruno RS. Green tea extract treatment reduces NFkappaB activation in mice with diet-induced nonalcoholic steatohepatitis by lowering TNFR1 and TLR4 expression and ligand availability. J Nutr Biochem. 2017 Mar;41:34-41. doi: 10.1016/j.jnutbio.2016.12.007. Epub 2016 Dec 21.'}, {'pmid': '29190550', 'type': 'BACKGROUND', 'citation': 'Li J, Sasaki GY, Dey P, Chitchumroonchokchai C, Labyk AN, McDonald JD, Kim JB, Bruno RS. Green tea extract protects against hepatic NFkappaB activation along the gut-liver axis in diet-induced obese mice with nonalcoholic steatohepatitis by reducing endotoxin and TLR4/MyD88 signaling. J Nutr Biochem. 2018 Mar;53:58-65. doi: 10.1016/j.jnutbio.2017.10.016. Epub 2017 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. It is completed in two phases. Phase I consists of a pharmacokinetic study to examine the bioavailability of green tea catechins among lean and obese persons who consumed a single dose of a green tea extract (GTE)-containing confection. These persons will then complete phase 2, which consists of a parallel design randomized controlled in which lean and obese persons will consume placebo or GTE confections.\n\nIt is expected that catechin-rich green tea will improve gut barrier function to prevent endotoxin translocation and associated low-grade inflammation. Outcomes will therefore support dietary recommendations for green tea to alleviate obesity-related inflammatory responses. Specifically, the study is expected to demonstrate that a green tea confection snack food can attenuate metabolic endotoxemia in association with restoring gastrointestinal health.', 'detailedDescription': 'Obesity is a major public health concern in the United States, with over two-thirds of the adult population classified as overweight or obese. Obesity is characterized by low-grade chronic inflammation that, in part, is mediated by metabolic endotoxemia. Metabolic endotoxemia describes increased circulating levels of gut-derived endotoxin (a bacterial product derived from Gram-negative bacteria in the intestines) that results from gut barrier dysfunction, a phenomenon that is common in obesity. Studies in rodents models have shown that dietary supplementation with green tea extract (GTE) reduces metabolic endotoxemia in association with improved gut health. This clinical trial will therefore investigate the extent to which a green tea confection snack food can alleviate metabolic endotoxemia and restore gut health in obese humans. It is hypothesized that 4-week daily ingestion of a green tea extract (GTE)-rich confection will limit metabolic endotoxemia by decreasing gut barrier permeability. This study will address the following objectives: 1) define alterations in catechin pharmacokinetics in obese compared with healthy adults, 2) demonstrate improvements in gut barrier function by GTE, and 3) demonstrate GTE-mediated amelioration of microbial dysbiosis.\n\nTo test the hypothesis, all participants will initially complete a 12-h pharmacokinetics study to define the influence of obesity on catechin bioavailability and metabolism. They will then be randomized to complete a double-blind, randomized, placebo-controlled trial where they will receive a GTE-rich or placebo confection for 4 weeks. Prior to and upon completing the intervention, participants will undergo a gut permeability test, fecal samples will be collected for microbiota composition analysis, and blood samples will be collected to assess endotoxin and inflammatory biomarkers. Upon successfully completing this study, it is anticipated that chronic consumption of a green tea confection will be demonstrated to be an effective dietary strategy to reduce metabolic endotoxemia and improve gut health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight/obese (BMI = 28-40 kg/m2)\n* Fasting glucose \\< 126 mg/dL\n* Normotensive (blood pressure \\< 140/90 mmHg)\n* Non-dietary supplement user\n* Non-smoker\n\nExclusion Criteria:\n\n* Regular tea drinkers (\\> 2 cups/week)\n* Vegetarians\n* Use of medications to manage diabetes, hypertension, or hyperlipidemia\n* Use of any medications known to be contraindicated for use with green tea ingestion\n* User of dietary supplements, prebiotics, or probiotics\n* Recent use of antibiotics or anti-inflammatory agents\n* Women who are pregnant or lactating or have initiated or changed birth control in the past 3-months\n* Individuals with gastrointestinal disorders or surgeries\n* Individuals with hemochromatosis\n* Alcohol intake \\> 3 drinks per day\n* Any history of cancer'}, 'identificationModule': {'nctId': 'NCT03413735', 'briefTitle': 'Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults', 'orgStudyIdInfo': {'id': '2017H0246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Confection', 'description': 'Confection without green tea extract consumed daily for 4 weeks', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Green Tea Extract-Confection', 'description': 'Confection with green tea extract consumed daily for 4 weeks', 'interventionNames': ['Other: Green Tea Extract']}], 'interventions': [{'name': 'Green Tea Extract', 'type': 'OTHER', 'description': 'Confections containing green tea extract that will be ingested daily for 4 weeks', 'armGroupLabels': ['Green Tea Extract-Confection']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Confections containing no green tea extract that will be ingested daily for 4 weeks', 'armGroupLabels': ['Placebo Confection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Richard Bruno, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Richard Bruno', 'investigatorAffiliation': 'Ohio State University'}}}}