Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT03513432
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2018-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001515', 'term': 'Beer'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000434', 'term': 'Alcoholic Beverages'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000088082', 'term': 'Fermented Beverages'}, {'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a three-arm parallel-group, randomized controlled study to evaluate the effect of consumption of beer with or without alcohol (5.20 %, 0.45 % and 0.00 %), during 4 weeks, on healthy individuals.\n\nThe study will focus on the effects of beer on microbiota and biochemical biomarkers in healthy human volunteers.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2018-04-12', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in intestinal microbiota from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)'}], 'secondaryOutcomes': [{'measure': 'Changes in fasting serum total cholesterol from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)'}, {'measure': 'Changes in fasting serum triglycerides from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)'}, {'measure': 'Changes in fasting serum cHDL from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)'}, {'measure': 'Changes in fasting serum cLDL from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)'}, {'measure': 'Changes in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)'}, {'measure': 'Changes in body mass index from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2.'}, {'measure': 'Changes in total body fat mass from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)'}, {'measure': 'Changes in fasting serum LPS levels from baseline', 'timeFrame': 'at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut microbiota', 'Beer', 'Alcohol', 'Cardiovascular disease'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Our aim is to assess the effects of moderate consumption of beer and non-alcoholic beer on gut microbiota and biochemical biomarkers in healthy adults.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult men (18-65 years);\n* Healthy volunteers free of chronic diseases with relevant effect on gastrointestinal system;\n* Without a diagnosis of any digestive disease including functional bowel disorders such as IBS;\n* Moderate alcohol consumers;\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Documented cardiovascular disease (ischaemic heart disease - angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease);\n* With diabetes or other relevant metabolic diseases;\n* With any known infectious diseases, namely infections with HIV, Hepatitis B or C virus;\n* Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks;\n* Subjects with history of drug, alcohol or other substances abuse.'}, 'identificationModule': {'nctId': 'NCT03513432', 'briefTitle': 'Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.', 'orgStudyIdInfo': {'id': 'MICROAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beer with 5.20 % alcohol', 'description': '330 ml beer (5.20 % alcohol)/day', 'interventionNames': ['Dietary Supplement: Beer with 5.20 % alcohol']}, {'type': 'EXPERIMENTAL', 'label': 'Non-alcoholic beer with 0.45 % alcohol', 'description': '330 ml non-alcoholic beer (0.45 % alcohol)/day', 'interventionNames': ['Dietary Supplement: Non-alcoholic beer with 0.45 % alcohol']}, {'type': 'EXPERIMENTAL', 'label': 'Non-alcoholic beer with 0.00 % alcohol', 'description': '330 ml non-alcoholic beer (0.00 % alcohol)/day', 'interventionNames': ['Dietary Supplement: Non-alcoholic beer with 0.00 % alcohol']}], 'interventions': [{'name': 'Beer with 5.20 % alcohol', 'type': 'DIETARY_SUPPLEMENT', 'description': '330 ml beer (5.20 % alcohol)/day during 4 weeks', 'armGroupLabels': ['Beer with 5.20 % alcohol']}, {'name': 'Non-alcoholic beer with 0.45 % alcohol', 'type': 'DIETARY_SUPPLEMENT', 'description': '330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks', 'armGroupLabels': ['Non-alcoholic beer with 0.45 % alcohol']}, {'name': 'Non-alcoholic beer with 0.00 % alcohol', 'type': 'DIETARY_SUPPLEMENT', 'description': '330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks', 'armGroupLabels': ['Non-alcoholic beer with 0.00 % alcohol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Faculdade de Ciências Médicas da Universidade NOVA de Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Conceição Calhau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NOVA Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Nova de Lisboa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}