Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-06-26 @ 4:46 AM
Study NCT ID:
NCT03746093
Status:
UNKNOWN
Last Update Posted:
2019-01-29
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2018-11-15', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in fasting capillary blood glucose from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}, {'measure': 'Changes in fasting insulin levels from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}, {'measure': 'Changes in HOMA-IR from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}, {'measure': 'Changes in HOMA-B from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}, {'measure': 'Changes in HbA1c levels from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}], 'secondaryOutcomes': [{'measure': 'Changes in intestinal microbiota from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)', 'description': 'Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.'}, {'measure': 'Changes in body mass index from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-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 to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}, {'measure': 'Changes in fasting serum total cholesterol from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}, {'measure': 'Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}, {'measure': 'Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}, {'measure': 'Changes in fasting serum triglycerides from baseline to visit 2 and 3', 'timeFrame': 'at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effects of non-alcoholic beer in patients with type 2 diabetes. Subjects will be divided into two groups: the control group, where participants will be consuming a bottle of water (330ml) every day for 12 weeks, and the intervention group, where participants will be consuming a bottle of non-alcoholic beer (330ml) for the same period.', 'detailedDescription': 'This is a parallel, controlled randomized trial. The study will compare the effect of non-alcoholic beer consumption with water, in patients with type 2 diabetes.\n\nAll patients from both groups will receive a personalized nutritional intervention and will be followed throughout the study by a certified nutritionist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;\n* Ages 40-80 years;\n* Non-smoker;\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Changes in oral glycaemic-control medications in the last 3 months;\n* Subjects with HbA1c levels under 6.4% or above 10%;\n* Subjects under insulinotherapy;\n* Subjects with triglycerides levels above 4.52 nmol/L(400 mg/dL);\n* Intake of antibiotics in the last 12 weeks;\n* Subjects not willing to avoid drinking beer during the study;\n* Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS;\n* Pregnant women or women planning to become pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT03746093', 'acronym': 'DIABEER', 'briefTitle': 'Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DIABEER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants will consume a bottle of water (330 ml) every day for 12 weeks.', 'interventionNames': ['Dietary Supplement: Water']}, {'type': 'EXPERIMENTAL', 'label': 'Non-alcoholic beer', 'description': 'Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.', 'interventionNames': ['Dietary Supplement: Non-alcoholic beer']}], 'interventions': [{'name': 'Water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will consume a bottle of water (330 ml) every day for 12 weeks.', 'armGroupLabels': ['Control Group']}, {'name': 'Non-alcoholic beer', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.', 'armGroupLabels': ['Non-alcoholic beer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1169-056', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Conceição Calhau', 'role': 'CONTACT', 'email': 'diabeer@nms.unl.pt', 'phone': '00351918482491'}], 'facility': 'NOVA Medical School, NOVA University of Lisbon', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'centralContacts': [{'name': 'Conceição Calhau', 'role': 'CONTACT', 'email': 'ccalhau@nms.unl.pt', 'phone': '+351218803000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Health Technology and Services Research', 'class': 'OTHER'}, {'name': 'NOVA Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}