Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:32 AM
Study NCT ID:
NCT07460856
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cranberry on Gut and Metabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glucose homeostasis', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of glucose concentrations during a 3-hour oral glucose tolerance test (OGTT)'}, {'measure': 'Change in insulin secretion', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of insulin a concentrations during a 3-hour oral glucose tolerance test (OGTT)'}, {'measure': 'Change in insulin secretion', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of C-Peptide concentrations during a 3-hour oral glucose tolerance test (OGTT)'}, {'measure': 'Change in lipid profile', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol'}], 'secondaryOutcomes': [{'measure': 'Change in other measures of glucose homeostasis', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of glycated hemoglobin (HbA1c)'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of systolic and diastolic blood pressure'}, {'measure': 'Change in chronic inflammation', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of plasma high sensitive C-Reactive Protein (hs-CRP) concentrations'}, {'measure': 'Change in anthropometric measurements', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of body mass index (BMI) using weight and height. These two measurements will be combined to calculate BMI in kg/m2'}, {'measure': 'Change in anthropometric measurements', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of waist circumference'}, {'measure': 'Change in body composition', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of changes in lean mass, fat mass and visceral fat mass (all in grams) using body composition by Dual X-ray Absorptiometry scan'}, {'measure': 'Change in gut microbiota', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of global variation of the fecal microbiota'}, {'measure': 'Change in gut microbiota function', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Assessment of short-chain fatty acid (SCFA) in feces'}, {'measure': 'Change in fat accumulation in the liver', 'timeFrame': 'Pre and post each treatment (12 week/each)', 'description': 'Evaluation of fat accumulation using magnetic resonance imaging (MRI) in a subgroup of women only.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight/Obesity', 'Metabolic Syndrome', 'Insulin Resistance', 'Microbiota']}, 'descriptionModule': {'briefSummary': 'The consumption of plant-based foods, particularly berries, has been associated with improved health due to their high content of bioactive compounds. Among these, polyphenols-especially proanthocyanidins (PACs)-may offer protective effects against chronic diseases related to overweight and obesity. Cranberries are naturally rich in PACs and may positively influence metabolic health by modulating the gut microbiota. However, their specific effects on intestinal integrity and broader metabolic outcomes remain underexplored.\n\nThe primary aim of this study is to assess the effects of cranberry supplementation on glucose metabolism, insulin sensitivity, blood lipid levels, and the composition and function of the gut microbiota in overweight and obese individuals.\n\nThis randomized, double-blind, placebo-controlled, crossover clinical trial will include two 12-week intervention periods-one with a cranberry beverage and one with a placebo-separated by a 4-week washout period and preceded by a 2-week lifestyle stabilization phase. Participants will undergo comprehensive metabolic assessments (glucose control, insulin sensitivity, lipid profile), body composition analysis, gut microbiota profiling, and liver fat imaging (MRI in a subsample of female participants). Additional evaluations will include markers of inflammation, appetite regulation, intestinal health, and lifestyle factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index between 25 and 40 kg/m2\n* at least one of the following criteria: fasting plasma insulin \\>60 pmol/L, fasting glycemia between 5.5 and 6.9 mmol/L, glycated hemoglobin (HbA1c) level of 5.7- 6.4% and/or fasting triglyceride \\>1.35 mmol/L.\n\nExclusion Criteria:\n\n* to have aversion to cranberry products\n* regularly drinking alcohol (\\>2 glasses/day)\n* having a significant change in body weight in the past 3 months (±5% of their body weight) due to bariatric surgery or other conditions\n* taking medication which may affect the study outcomes (i.e. antidiabetic and/or cholesterol or lipid-lowering medications and/or glucocorticosteroid in supraphysiological doses and/or anti-obesity medications)\n* taking regular probiotics and prebiotics (including fruit/berry polyphenol supplements) in the past 3 months\n* having eating disorders\n* had undergone major surgery 3 months prior to the study or if they had one planned\n* if they had intestinal malabsorption, cirrhosis or chronic kidney disease\n* being pregnant, planning a pregnancy, or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07460856', 'acronym': 'CRANOS', 'briefTitle': 'Effects of Cranberry on Gut and Metabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Effects of Cranberry on Gut and Metabolic Health', 'orgStudyIdInfo': {'id': 'CRANOS 2024-530'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cranberry beverage', 'interventionNames': ['Dietary Supplement: Cranberry beverage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo beverage', 'interventionNames': ['Dietary Supplement: Placebo beverage']}], 'interventions': [{'name': 'Cranberry beverage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily consumption of 240 ml of cranberry beverage for 12 weeks.', 'armGroupLabels': ['Cranberry beverage']}, {'name': 'Placebo beverage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily consumption of 240 ml of placebo beverage for 12 weeks.', 'armGroupLabels': ['Placebo beverage']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V0A6', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Julie Marois, M.Sc.', 'role': 'CONTACT', 'email': 'julie.marois@fsaa.ulaval.ca', 'phone': '1-418-656-5258'}], 'facility': 'INAF, Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Julie Marois, M.Sc.', 'role': 'CONTACT', 'email': 'julie.marois@fsaa.ulaval.ca', 'phone': '1-418-656-5258'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ocean Spray Cranberries, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'André Marette', 'investigatorAffiliation': 'Laval University'}}}}