Clinical trial NCT05917132: Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles
Official title: Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Abdominal
Diabete Type 2
Keywords: Gut Microbiome
Endocannabinoidome
Metabolites
Microbiome-Endocannabinoidome Axis
Obesity
Type 2 Diabetes
Nutrition
Fatty Acids
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes
timeFrame: 7 days
Secondary outcomes:
measure: Gut microbiota in response to a 2 day dietary lipid intervention in abdominal obesity and type 2 diabetes
timeFrame: 7 days
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut sur la nutrition et les aliments fonctionnels - INAF
state: Quebec
Study officials:
affiliation: Laval University
name: Alain Veilleux, PhD
role: PRINCIPAL_INVESTIGATOR
References: