Clinical trial NCT03463304: Environmental Factors and the Gut Microbiome - Endocannabinoid Axis
Official title: The Influence of Host Environmental Factors on the Gut Microbiome - Endocannabinoid Axis in Metabolic and Mental Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Habits
Energy Metabolism
Mental Health Wellness 1
Intestinal Disease
Keywords: Gut Microbiota
endocannabinoide
Metabolic health
Gastrointestinal health
Mental wellbeing
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Free-living adults with various body composition, dietary habits and daily physical activity levels from the Quebec city region.

Brief summary: The general objective of this project is to investigate the interplay of the gut microbiome - endocannabinoid axis with host environmental factors and intestinal, metabolic and mental health status in free-living adults with various metabolic statuses and lifestyles.

Detailed description: The gut microbiome and the endocannabinoid system (ECS) could be interacting together and influence local enteric and peripheral metabolic functions and mental health.

The association of some host environmental factors (e.g. age, metabolic status, dietary habits) with gut microbiota composition and function has been investigated but, to our knowledge, little is known about their influence on the ECS.

There is also a need to better understand the influence of these factors and the interplay between the gut microbiota and the ECS and their relationship with intestinal, metabolic and mental health.

The investigators therefore propose to fill this knowledge-gap in the general population of adults with various body composition, dietary habits and daily physical activity levels.

Eligibility criteria: Inclusion Criteria:

* Computer and internet access
* Understanding of written French

Exclusion Criteria:

* Intestinal pathologies
* Pregnancy or breast-feeding
* Recent significant weight variations
* Recent completion of antibiotic treatment
* Alcohol consumption over sex-specific recommendations

Primary outcomes:
measure: Evaluation of the influence of dietary habits assessed via Food Frequency Questionnaire (FFQ) on the relationship between gut microbiota composition and circulating endocannabinoids
timeFrame: September 2018
Secondary outcomes:
measure: Evaluation of the effect of adiposity assessed by Dual-energy X-ray Absorptiometry (DXA) scan on the relationship between gut microbiota composition and circulating endocannabinoids.
timeFrame: September 2018
measure: Evaluation of the effect of fasting glycemia on the relationship between gut microbiota composition and circulating endocannabinoids.
timeFrame: September 2018
measure: Evaluation of the effect of fasting triglyceridemia on the relationship between gut microbiota composition and circulating endocannabinoids.
timeFrame: September 2018
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: