Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-05 @ 5:16 PM
Study NCT ID:
NCT05917132
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes', 'timeFrame': '7 days', 'description': 'Interindividual variations in the endocannabinoidome mediators levels following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.'}], 'secondaryOutcomes': [{'measure': 'Gut microbiota in response to a 2 day dietary lipid intervention in abdominal obesity and type 2 diabetes', 'timeFrame': '7 days', 'description': 'Interindividual variations in the gut microbiota composition following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut Microbiome', 'Endocannabinoidome', 'Metabolites', 'Microbiome-Endocannabinoidome Axis', 'Obesity', 'Type 2 Diabetes', 'Nutrition', 'Fatty Acids'], 'conditions': ['Obesity, Abdominal', 'Diabete Type 2']}, 'descriptionModule': {'briefSummary': 'The proposed project mainly aims to investigate the microbial processes leading to dietary metabolites production, independently of long-term microbiota adaptation to the diet, by measuring the microbiota-derived metabolite production from a meal sequence rich in saturated fatty acids (SFA) or the same meals but rich in polyunsaturated fatty acids (PUFA) in individuals with or without obesity and Type 2 diabetes (T2D)', 'detailedDescription': "The gut microbiota interacts with the host's enteric and systemic functions through the production of gut microbiota-derived metabolites. A subset of these metabolites, the endocannabinoids (eCB) and their congeners are derived from fatty acids and play a crucial role in metabolic health.\n\nThe research project aims to study gut microbiota-derived metabolites, including the eCB and their congeners, in response to a 2-day diet rich in polyunsaturated fatty acids or rich in saturated fatty acids in individuals with or without abdominal obesity and type 2 diabetes.\n\nThe investigators hope to better understand the kinetic production of circulating endocannabinoidome mediators derived from fatty acids in the diet."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged between 45 and 65 years, menopaused women ;\n* Body mass index between 20 to 35 kg/m² ;\n* General good health ;\n* Score of diet quality (HEI) between 40 and 70 ;\n* Computer and Internet access ;\n* Basic understanding of written French ;\n* Daily stool frequency.\n\nExclusion Criteria:\n\n* Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers ;\n* Alcohol consumption greater than 15 portions for men and 10 for women weekly.\n* Active tobacco and cannabis usage ;\n* Consumption of omega-3 dietary supplements ;\n* Consumption of dietary supplements (vitamins and probiotics) - must be ceased 2 weeks before the dietary intervention ;\n* Completion of a course of antibiotics in the past 3 months ;\n* Important weight change (+/- 5 kg) in the past 6 months ;\n* Type 1 diabetes or insulin-treated diabetes.'}, 'identificationModule': {'nctId': 'NCT05917132', 'acronym': 'METAc', 'briefTitle': 'Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles', 'orgStudyIdInfo': {'id': '2022-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single', 'description': 'All participating subjects will undergo 3 feeding phases : 3 days of a run-in diet, 2 days of a polyunsaturated fatty acid (PUFA) diet and 2 days of a saturated fatty acid (SFA) diet.', 'interventionNames': ['Other: Nutritionnal intervention']}], 'interventions': [{'name': 'Nutritionnal intervention', 'type': 'OTHER', 'description': 'Participants will be provided with meals corresponding to each diet during the week. Participants will be required to eat only the meals provided.', 'armGroupLabels': ['Single']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 0A6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut sur la nutrition et les aliments fonctionnels - INAF', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Alain Veilleux, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alain Veilleux', 'investigatorAffiliation': 'Laval University'}}}}