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CompletedNCT03463304eMECAUpdated Feb 28, 2020

Environmental Factors and the Gut Microbiome - Endocannabinoid Axis

An observational study in Food Habits, Energy Metabolism and Mental Health Wellness 1, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Laval University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
204
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Food Habits
  • Energy Metabolism
  • Mental Health Wellness 1
  • Intestinal Disease

Keywords

  • Gut Microbiota
  • endocannabinoide
  • Metabolic health
  • Gastrointestinal health
  • Mental wellbeing
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In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 204 is above the median of 183 across 270 observational studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Computer and internet access
  • Understanding of written French

Exclusion criteria

Exclusion Criteria:

  • Intestinal pathologies
  • Pregnancy or breast-feeding
  • Recent significant weight variations
  • Recent completion of antibiotic treatment
  • Alcohol consumption over sex-specific recommendations
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
204 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Evaluation of the influence of dietary habits assessed via Food Frequency Questionnaire (FFQ) on the relationship between gut microbiota composition and circulating endocannabinoids

    FFQ items will be used to identify dietary habits by unsupervised clustering to evaluate their association with gut microbiota composition obtained from ribosomal RNA sequencing and plasma endocannabinoid (e.g. Arachidonoylethanolamide, 2 arachidonoyl glycerol and their derivatives) concentrations.

    Time frame: September 2018

Secondary outcomes

  1. 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.

    The effect of adiposity measured by DXA scan on the relationship between gut microbiota composition and diversity obtained from ribosomal RNA sequencing and plasma endocannabinoids (e.g. Arachidonoylethanolamide, 2 arachidonoyl glycerol and their derivatives) will be investigated.

    Time frame: September 2018

  2. Evaluation of the effect of fasting glycemia on the relationship between gut microbiota composition and circulating endocannabinoids.

    The effect of fasting glycemia, used to infer metabolic status, on the relationship between gut microbiota composition and diversity obtained from ribosomal RNA sequencing and plasma endocannabinoids (e.g. Arachidonoylethanolamide, 2 arachidonoyl glycerol and their derivatives) will be investigated.

    Time frame: September 2018

  3. Evaluation of the effect of fasting triglyceridemia on the relationship between gut microbiota composition and circulating endocannabinoids.

    The effect of fasting triglyceridemia, used to infer metabolic status, on the relationship between gut microbiota composition and diversity obtained from ribosomal RNA sequencing and plasma endocannabinoids (e.g. Arachidonoylethanolamide, 2 arachidonoyl glycerol and their derivatives) will be investigated.

    Time frame: September 2018

07

Study locations

1 site
  • Institut sur la nutrition et les aliments fonctionnels - INAF
    Québec, Quebec G1V 0A6, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03463304
Lead sponsor
Laval University
Responsible party
Alain Veilleux (Affiliated Professor, Laval University) — Principal investigator
First posted
Mar 13, 2018
Start date
Feb 13, 2018
Primary completion
Sep 30, 2018
Completion
Dec 30, 2018
Last update
Feb 28, 2020

Study contacts

Alain Veilleux, PhD
principal investigator · Laval University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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