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

Obesity, Abdominal Clinical Trial

— METAc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917132
• Other study ID #: 2022-109
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: June 12, 2025

Study information

• Verified date: December 2023
• Source: Laval University
• Contact: Alain Veilleux, PhD
• Phone: 418 656-3527
• Email: alain.veilleux[@]fsaa.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 12, 2025
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Obesity, Abdominal

Intervention

Other:
• Nutritionnal intervention
Participants will be provided with meals corresponding to each diet during the week. Participants will be required to eat only the meals provided.

Locations

Country	Name	City	State
Canada	Institut sur la nutrition et les aliments fonctionnels - INAF	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes	Interindividual variations in the endocannabinoidome mediators levels following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.	7 days
Secondary	Gut microbiota in response to a 2 day dietary lipid intervention in abdominal obesity and type 2 diabetes	Interindividual variations in the gut microbiota composition following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.	7 days