Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-04 @ 9:49 PM
Study NCT ID:
NCT07131904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-alcoholic, Fiber-enriched Beer and Its Effect on Blood Glucose Concentration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose', 'timeFrame': '0-120 minutes after beverage consumption on each test day', 'description': 'Incremental area under the curve for interstitial glucose concentration measured over 120 minutes after beverage consumption. Measurements obtained via continuous glucose monitoring (FreeStyle Libre 3) in a randomized crossover design.'}], 'secondaryOutcomes': [{'measure': 'Glycemic Index of Fiber-Enriched Beer (FEB)', 'timeFrame': '0-120 minutes after beverage consumption on each test day', 'description': 'Glycemic index calculated using the incremental area under the curve for blood glucose after consumption of FEB, compared to glucose solution, according to ISO 26642:2010 methodology.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fiber-enriched beer', 'functional food', 'continuous glucose monitoring', 'postprandial glucose response'], 'conditions': ['Blood Glucose Concentration', 'Glycemic Index', 'Dietary Fiber', 'Non-alcoholic Beer']}, 'descriptionModule': {'briefSummary': 'This study examines how various non-alcoholic beverages affect blood sugar levels.\n\nThe beverages are a non-alcoholic, fiber-enriched beer, a conventional non-alcoholic beer, and a sugar solution. Participants drink one of these beverages on different days. Afterwards, a sensor on the upper arm is used to measure the sugar content in the body fluid under the skin over a period of two hours.\n\nThe aim is to find out how much blood sugar concentration rises after drinking. This will be used to check whether the non-alcoholic, fiber-enriched beer has a more favorable effect on sugar metabolism than conventional beverages. Participation is voluntary, and the data will be treated confidentially.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged 18-60 years\n* Body mass index (BMI) between 18.5 and 29.9 kg/m²\n* Signed informed consent\n\nExclusion Criteria:\n\n* Diagnosed diabetes\n* Gastrointestinal diseases\n* Hormonal or other metabolic diseases\n* Allergies or intolerances to beer ingredients\n* Professional sports (\\>10 hours/week of intense exercise)\n* Special diets (e.g., low-carb, intermittent fasting)\n* Sleep disorders or inability to maintain regular sleep (e.g., shift work)\n* Pregnancy or breastfeeding\n* Smoking\n* Inability to speak German or English\n* Problems with alcohol, drug, or medication abuse\n* Inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07131904', 'briefTitle': 'Non-alcoholic, Fiber-enriched Beer and Its Effect on Blood Glucose Concentration', 'organization': {'class': 'OTHER', 'fullName': 'Bern University of Applied Sciences'}, 'officialTitle': 'Non-alcoholic, Fiber-enriched Beer and Its Effect on Blood Glucose Concentration: A Scientific Study', 'orgStudyIdInfo': {'id': 'Fiberbeer trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non-alcoholic, fiber-enriched beer (FEB)', 'interventionNames': ['Other: non-alcoholic, fiber-enriched beer (FEB)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional, non-alcoholic beer', 'interventionNames': ['Other: conventional, non-alcoholic beer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'glucose solution', 'interventionNames': ['Other: glucose solution']}], 'interventions': [{'name': 'non-alcoholic, fiber-enriched beer (FEB)', 'type': 'OTHER', 'description': '500 ml FEB consumed once during a test day in a randomized crossover design. Postprandial blood glucose is monitored for 120 minutes using a continuous glucose monitor (FreeStyle Libre 3).', 'armGroupLabels': ['non-alcoholic, fiber-enriched beer (FEB)']}, {'name': 'conventional, non-alcoholic beer', 'type': 'OTHER', 'description': '500 ml conventional non-alcoholic beer consumed once during a test day in a randomized crossover design. Postprandial blood glucose is monitored for 120 minutes using a continuous glucose monitor (FreeStyle Libre 3).', 'armGroupLabels': ['conventional, non-alcoholic beer']}, {'name': 'glucose solution', 'type': 'OTHER', 'description': 'Glucose solution containing 12.5 g glucose in 500 ml water, consumed once during a test day in a randomized crossover design. Postprandial blood glucose is monitored for 120 minutes using a continuous glucose monitor (FreeStyle Libre 3).', 'armGroupLabels': ['glucose solution']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David Fäh, Prof.Dr.med', 'role': 'CONTACT', 'email': 'david.faeh@bfh.ch', 'phone': '+41 31 848 45 51'}, {'name': 'Neeser Lorena, Bsc', 'role': 'CONTACT', 'email': 'lorena.neeser@bfh.ch', 'phone': '+41 77 423 18 45'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Faeh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. David Fäh', 'investigatorFullName': 'David Faeh', 'investigatorAffiliation': 'Bern University of Applied Sciences'}}}}