Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles

Not Applicable

Recruiting

• Conditions: Diabete Type 2; Obesity, Abdominal
• Interventions: Other: Nutritionnal intervention

• Registration Number: NCT05917132
• Lead Sponsor: Laval University

Brief Summary

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)

Detailed Description

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.

The 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.

The investigators hope to better understand the kinetic production of circulating endocannabinoidome mediators derived from fatty acids in the diet.

Study Timeline

• Study Start: 2023-06-12
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-09
• Last Update Posted: 2023-12-15
• Primary Completion: 2024-06-12
• Study Completion: 2025-06-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Men and women aged between 45 and 65 years, menopaused women ;
• Body mass index between 20 to 35 kg/m² ;
• General good health ;
• Score of diet quality (HEI) between 40 and 70 ;
• Computer and Internet access ;
• Basic understanding of written French ;
• Daily stool frequency.

Exclusion Criteria

• Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers ;
• Alcohol consumption greater than 15 portions for men and 10 for women weekly.
• Active tobacco and cannabis usage ;
• Consumption of omega-3 dietary supplements ;
• Consumption of dietary supplements (vitamins and probiotics) - must be ceased 2 weeks before the dietary intervention ;
• Completion of a course of antibiotics in the past 3 months ;
• Important weight change (+/- 5 kg) in the past 6 months ;
• Type 1 diabetes or insulin-treated diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single	Nutritionnal intervention	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.

Primary Outcome Measures

Name	Time	Method
Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes	7 days	Interindividual variations in the endocannabinoidome mediators levels following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.

Secondary Outcome Measures

Name	Time	Method
Gut microbiota in response to a 2 day dietary lipid intervention in abdominal obesity and type 2 diabetes	7 days	Interindividual variations in the gut microbiota composition following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.

Trial Locations

Locations (1)

Institut sur la nutrition et les aliments fonctionnels - INAF; 🇨🇦 Québec, Quebec, Canada