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OpenTrials
Completed

NCT Number: NCT05917132

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

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)

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut sur la nutrition et les aliments fonctionnels - INAF

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: METAc

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2023
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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