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Completed

NCT Number: NCT03463304

Environmental Factors and the Gut Microbiome - Endocannabinoid Axis

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.

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Key information

Conditions

Food Habits Behavior Behavior, Animal Digestive System Diseases Energy Metabolism Feeding Behavior Gastrointestinal Diseases Intestinal Disease Intestinal Diseases Mental Health Wellness 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut sur la nutrition et les aliments fonctionnels - INAF

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    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.

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.

    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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Acronym: eMECA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2018
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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