Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06745102
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hop Compounds on the Immune System in Overweight People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C104536', 'term': 'xanthohumol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in parameters of immune response', 'timeFrame': '6 hours', 'description': 'Changes in concentration of interleukin 6 (ng/ml) in cell culture supernatant of stimulated cells'}, {'measure': 'Changes in parameters of immune response', 'timeFrame': '6 hours', 'description': 'Changes in concentrations of interleukin 1 beta (ng/ml) in cell culture supernatant of stimulated cells'}, {'measure': 'Changes in parameters of immune response', 'timeFrame': '6 hours', 'description': 'Changes in concentration of tumor necrosis factor alpha (ng/ml) in cell culture supernatant of stimulated cells'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to determine the effect of Iso-alpha Acids and Xanthohumol from hops on the immune response in overweight participants.', 'detailedDescription': 'The aim of the present study is to investigate whether the oral intake of Xanthohumol and Iso-alpha Acids has different protective effects on the immune response of isolated blood cells from overweight people with people with incipient metabolic diseases, what the time course of the effect is and whether the levels of the substances differ from normal-weight individuals.\n\nAfter taking a fasting blood sample, the study participants receive one of the study drinks and a light breakfast. Both should be consumed within 15 minutes. Further blood samples are taken 1, 2, 3, 4 and 6 hours after the drinks have been consumed. To assess the effect of Xanthohumol and Iso-alpha Acids or a combination of both, clinical parameters, blood lipids, blood glucose, uric acid and inflammatory markers will be determined. Furthermore, blood cells, isolated from blood samples of each time point, will be stimulated for measuring inflammatory markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 25 - 29,9 kg/m²\n\nas well as one or more of the following incipient metabolic diseases:\n\n* pre-diabetes (fasting blood glucose 100-125 mg/dL),\n* fatty liver (grade 1-3),\n* high-normal blood pressure to mild hypertension (grade 1, systolic 140-159 mmHg)\n\nExclusion Criteria:\n\n* History of diseases that could falsify the study results\n* inflammatory bowel diseases\n* malignant diseases of the gastrointestinal tract\n* food allergies\n* malabsorption\n* kidney or liver disease (except simple fatty liver)\n* symptomatic heart failure\n* Taking medication to treat these diseases\n* Consumption of special diets (e.g. vegan, gluten-free)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06745102', 'acronym': 'ÜG', 'briefTitle': 'Hop Compounds on the Immune System in Overweight People', 'organization': {'class': 'OTHER', 'fullName': 'University of Vienna'}, 'officialTitle': 'Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System in Overweight People With the Onset of Metabolic Diseases', 'orgStudyIdInfo': {'id': 'UVienna24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xanthohumol', 'description': 'Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo or 0.75 mg soluble Xanthohumol)', 'interventionNames': ['Dietary Supplement: Xanthohumol']}, {'type': 'EXPERIMENTAL', 'label': 'Iso-alpha Acids', 'description': 'Participants receive a study drink supplemented with Iso-alpha Acids (0 mg = Placebo or 45 mg Iso-alpha Acids)', 'interventionNames': ['Dietary Supplement: Iso-alpha Acids']}, {'type': 'EXPERIMENTAL', 'label': 'Xanthohumol + Iso-alpha Acids', 'description': 'Participants receive a study drink supplemented with Xanthohumol + Iso-alpha Acids (0 mg = Placebo or 0.75 mg + 45 mg soluble Xanthohumol + Iso-alpha Acids)', 'interventionNames': ['Dietary Supplement: Xanthohumol + Iso-alpha Acids']}], 'interventions': [{'name': 'Xanthohumol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receive a study drink supplemented with Xanthohumol (0 mg = Placebo or 0.75 mg soluble Xanthohumol)', 'armGroupLabels': ['Xanthohumol']}, {'name': 'Iso-alpha Acids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receive a study drink supplemented with Iso-alpha Acids (0 mg = Placebo or 45 mg Iso-alpha Acids)', 'armGroupLabels': ['Iso-alpha Acids']}, {'name': 'Xanthohumol + Iso-alpha Acids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receive a study drink supplemented with Xanthohumol and Iso-alpha Acids (0 mg = Placebo or 0.75 mg + 45 mg soluble Xanthohumol + Iso-alpha Acids)', 'armGroupLabels': ['Xanthohumol + Iso-alpha Acids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ina Bergheim, Prof. Dr.', 'role': 'CONTACT', 'email': 'ina.bergheim@univie.ac.at', 'phone': '+43-1-4277-54981'}], 'facility': 'University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Dr. Ina Bergheim', 'investigatorAffiliation': 'University of Vienna'}}}}