Food HabitseMECANCT03463304
Environmental Factors and the Gut Microbiome - Endocannabinoid Axis
An observational study of Food Habits and Energy Metabolism, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Habits, Energy Metabolism, Mental Health Wellness 1
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2018to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Free-living adults with various body composition, dietary habits and daily physical activity levels from the Quebec city region.
Who may be able to join
- Computer and internet access
- Understanding of written French
Who cannot join
- Intestinal pathologies
- Pregnancy or breast-feeding
- Recent significant weight variations
- Recent completion of antibiotic treatment
- Alcohol consumption over sex-specific recommendations
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut sur la nutrition et les aliments fonctionnels - INAF
Québec, Quebec, G1V 0A6
About this study
Official title: The Influence of Host Environmental Factors on the Gut Microbiome - Endocannabinoid Axis in Metabolic and Mental Health
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.
- Keywords
- Gut Microbiota, endocannabinoide, Metabolic health, Gastrointestinal health, Mental wellbeing
- Medical subject headings
- Feeding Behavior, Intestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 2018
Secondary outcomes (3)
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.
Measured: September 2018
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.
Measured: September 2018
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.
Measured: September 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start13 Feb 2018
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Veilleux, Laval University
- Investigators
- Alain Veilleux, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463304
- Sponsor's protocol ID
- 2017-328
- Acronym
- eMECA
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Castonguay-Paradis S, Demers-Potvin E, Rochefort G, Lacroix S, Perron J, Martin C, Flamand N, Raymond F, Di Marzo V, Veilleux A. Seasonal variations in circulating endocannabinoidome mediators and gut microbiota composition in humans. Gut Microbes. 2025 Dec;17(1):2476563. doi: 10.1080/19490976.2025.2476563. Epub 2025 Mar 20.
PubMed 40111342
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Host Environmental Factors on the Gut Microbiome - Endocannabinoid Axis in Metabolic and Mental Health
- ClinicalTrials.gov ID
- NCT03463304
- Acronym / sponsor ID
- eMECA / 2017-328
- Keywords
- Gut Microbiota, endocannabinoide, Metabolic health, Gastrointestinal health, Mental wellbeing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Free-living adults with various body composition, dietary habits and daily physical activity levels from the Quebec city region.
Key inclusion criteria (2 listed)
- Computer and internet access
- Understanding of written French
Key exclusion criteria (5 listed)
- Intestinal pathologies
- Pregnancy or breast-feeding
- Recent significant weight variations
- Recent completion of antibiotic treatment
- Alcohol consumption over sex-specific recommendations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Evaluation of the effect of fasting glycemia on the relationship between gut microbiota composition and circulating endocannabinoids.
Time frame: September 2018
Evaluation of the effect of fasting triglyceridemia on the relationship between gut microbiota composition and circulating endocannabinoids.
Time frame: September 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Derived from this study: PubMed 40111342Castonguay-Paradis S, Demers-Potvin E, Rochefort G, Lacroix S, Perron J, Martin C, Flamand N, Raymond F, Di Marzo V, Veilleux A. Seasonal variations in circulating endocannabinoidome mediators and gut microbiota composition in humans. Gut Microbes. 2025 Dec;17(1):2476563. doi: 10.1080/19490976.2025.2476563. Epub 2025 Mar 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Veilleux, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Habits and Energy Metabolism, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.