- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03463304
Environmental Factors and the Gut Microbiome - Endocannabinoid Axis (eMECA)
The Influence of Host Environmental Factors on the Gut Microbiome - Endocannabinoid Axis in Metabolic and Mental Health
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Quebec
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Québec, Quebec, Canada, G1V 0A6
- Institut sur la nutrition et les aliments fonctionnels - INAF
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the influence of dietary habits assessed via Food Frequency Questionnaire (FFQ) on the relationship between gut microbiota composition and circulating endocannabinoids
Time Frame: 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.
|
September 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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.
|
September 2018
|
Evaluation of the effect of fasting glycemia on the relationship between gut microbiota composition and circulating endocannabinoids.
Time Frame: 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.
|
September 2018
|
Evaluation of the effect of fasting triglyceridemia on the relationship between gut microbiota composition and circulating endocannabinoids.
Time Frame: 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.
|
September 2018
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alain Veilleux, PhD, Laval University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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