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

NCT05917132 | Completed

• 1 other identifier: 2022-109
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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)

Conditions

Obesity, Abdominal; Diabete Type 2

Keywords

Gut Microbiome; Endocannabinoidome; Metabolites; Microbiome-Endocannabinoidome Axis; Obesity; Type 2 Diabetes; Nutrition; Fatty Acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gut microbiota in response to a 2 day dietary lipid intervention in abdominal obesity and type 2 diabetes

  7 days

Study Arms (1)

Single

EXPERIMENTAL

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.

Other: Nutritionnal intervention

Interventions

Nutritionnal intervention OTHER

Participants will be provided with meals corresponding to each diet during the week. Participants will be required to eat only the meals provided.

Single

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut sur la nutrition et les aliments fonctionnels - INAF

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Obesity, Abdominal; Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alain Veilleux, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 23, 2023
• Study Start: June 12, 2023
• Primary Completion: May 31, 2024
• Study Completion: December 1, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CA (1)