eMECA: Environmental Factors and the Gut Microbiome - Endocannabinoid Axis

Sponsor
Laval University (Other)
Overall Status
Completed
CT.gov ID
NCT03463304
Collaborator
(none)
204
1
10.5
19.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    204 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    The Influence of Host Environmental Factors on the Gut Microbiome - Endocannabinoid Axis in Metabolic and Mental Health
    Actual Study Start Date :
    Feb 13, 2018
    Actual Primary Completion Date :
    Sep 30, 2018
    Actual Study Completion Date :
    Dec 30, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the influence of dietary habits assessed via Food Frequency Questionnaire (FFQ) on the relationship between gut microbiota composition and circulating endocannabinoids [September 2018]

      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.

    Secondary Outcome Measures

    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. [September 2018]

      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.

    2. Evaluation of the effect of fasting glycemia on the relationship between gut microbiota composition and circulating endocannabinoids. [September 2018]

      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.

    3. Evaluation of the effect of fasting triglyceridemia on the relationship between gut microbiota composition and circulating endocannabinoids. [September 2018]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut sur la nutrition et les aliments fonctionnels - INAF Québec Quebec Canada G1V 0A6

    Sponsors and Collaborators

    • Laval University

    Investigators

    • Principal Investigator: Alain Veilleux, PhD, Laval University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alain Veilleux, Affiliated Professor, Laval University
    ClinicalTrials.gov Identifier:
    NCT03463304
    Other Study ID Numbers:
    • 2017-328
    First Posted:
    Mar 13, 2018
    Last Update Posted:
    Feb 28, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alain Veilleux, Affiliated Professor, Laval University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2020