Environmental Factors and the Gut Microbiome - Endocannabinoid Axis

Mental Health Wellness 1 Clinical Trial

— eMECA  

Official title:

The Influence of Host Environmental Factors on the Gut Microbiome - Endocannabinoid Axis in Metabolic and Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463304
• Other study ID #: 2017-328
• Status: Completed
• Start date: February 13, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2020
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Institut sur la nutrition et les aliments fonctionnels - INAF	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	September 2018
Secondary	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.	September 2018
Secondary	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.	September 2018
Secondary	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.	September 2018