Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-02 @ 4:37 AM
Study NCT ID:
NCT07089732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011236', 'term': 'Prediabetic State'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in BMI at weeks 8 and 12', 'timeFrame': 'Week 0, 8 and 12', 'description': 'Assessment of changes in BMI at baseline, week 8, and week 12'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in blood glucose at weeks 8 and 12', 'timeFrame': 'Week 0, 8 and 12', 'description': 'Assessment of blood glucose changes at weeks 0, 8, and 12'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Prediabetes']}, 'descriptionModule': {'briefSummary': 'A clinical human dietary intervention trial was conducted to investigate the effects of GLP-1 FORMUL liquid supplementation in individuals with prediabetes or obesity, with a focus on improvements in glycemic and lipid parameters, body composition, and gut microbiota profiles.', 'detailedDescription': 'This 12-week randomized, placebo-controlled clinical trial aims to evaluate the nutritional and metabolic effects of GLP-1 FORMULA liquid supplementation. A total of 100 adult participants will be recruited and randomly assigned to one of two groups: (1) placebo group (n = 50), and (2) GLP-1 FORMULA group (n = 50). Participants will consume one bottle (50 g) of either GLP-1 FORMULA or placebo 30 minutes prior to their first meal each day for 8 weeks, followed by a 4-week post-intervention observation period.\n\nThroughout the study, participants will undergo nutritional assessments including body composition analysis, waist-to-hip ratio measurements, appetite rating scales, gastrointestinal symptom questionnaires, and the Patient Health Questionnaire. Additionally, oral glucose tolerance tests (OGTT), standard blood biochemistry analyses, and fecal sample collection will be conducted at designated time points to evaluate glycemic control, metabolic markers, and gut microbiota composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 to 70 years.\n* Clinically diagnosed with prediabetes (fasting plasma glucose: 100-125 mg/dL or HbA1c: 5.7-6.4%) or with a body mass index (BMI) of 25-34.9 kg/m², male or female.\n* Have not participated in similar clinical studies within the past three months.\n* Able to comprehend the informed consent form, including the study procedures, potential risks, and benefits, and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosed with autoimmune diseases or cancer.\n* Diagnosed with gastrointestinal chronic diseases such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, celiac disease, bowel control disorders, fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, ulcerative colitis, lactose intolerance, or chronic diarrhea.\n* History of gastrointestinal surgery.\n* Planning pregnancy in the near future (including male partners), currently pregnant, or breastfeeding women.\n* Known allergy or hypersensitivity to probiotics or any of the study product ingredients.\n* History of major psychiatric disorders.\n* History of substance abuse or alcohol dependency."}, 'identificationModule': {'nctId': 'NCT07089732', 'briefTitle': 'Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Evaluation of the Effects of GLP-1 Formula Liquid Drink on Gut Microbiota Modulation and Blood Glucose Regulation in Prediabetic Populations', 'orgStudyIdInfo': {'id': 'CS2-24199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLP-1 formula liquid drink', 'description': 'GLP-1 formula liquid drink, 50 g/glass jar', 'interventionNames': ['Dietary Supplement: GLP-1 formula liquid drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'GLP-1 formula liquid drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One glass jar (50 g) of the GLP-1 formula liquid drink was administered once daily, 30 minutes prior to the first meal of the day.', 'armGroupLabels': ['GLP-1 formula liquid drink']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402 Recruiting', 'city': 'Taichung', 'state': 'South', 'country': 'Taiwan', 'contacts': [{'name': 'Chin-Lin Hsu Professor', 'role': 'CONTACT', 'email': 'clhsu@csmu.edu.tw', 'phone': '04-24730022 Ext. 12222'}], 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chin-Lin Hsu Professor', 'role': 'CONTACT', 'email': 'clhsu@csmu.edu.tw', 'phone': '04-24730022 Ext. 12222'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}