Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity (PerOME)

February 19, 2021 updated by: Laval University

Effect of Dietary Composition on the Gut Microbiota / Endocannabinoidome Axis in Response to Maximal Aerobic Exercise

Both the endocannabinoid system and the microbiome are highly conditioned by nutrition and physical activity, and have an interdependent, bidirectional relationship. We suggest studying the interleaving between the endocannabinoidome-microbiome axis and host metabolism under the combined effect of a diet and physical activity. More specificly, we will study the link between the impact of the diet on the intestinal microbiome and the endocannabinoid reaction after intense exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aims of the study are to compare the impacts of two short 7-day contrasted nutritional interventions (the Mediterranean diet (MED) and the Canadian diet (CAN)) on blood metabolites (endocannabinoids) after a maximal aerobic test. A 3 weeks washout between the two diets is planned. Gut microbiome at each test will also be evaluated.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V0A6
        • Institut sur la nutrition et les aliments fonctionnels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women
  • 20-30 years old
  • healthy
  • jogging >1h/week and >3h/week of physical activity
  • bmi 18.5-25

Exclusion Criteria:

  • postmenopausal, pregnancy or lactation
  • pathology or medication
  • smoking
  • more than 7 alcohol consumption/week
  • food allergy, food intolerance or food aversion
  • important weight change in the last 6 months
  • antibiotics in the last 3 months
  • night worker
  • pathologies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediterannen diet
The MED diet was abundant in fiber, micronutrients and plant-based proteins. The diet was rich in essential FA like monounsaturated fatty acids (MUFA) and n-3.
Other: 3 maximal aerobic tests
Maximal aerobic tests will be performed before diet intervention, after the first diet and after the second diet
Experimental: Canadian diet
The NAM diet had a high content in saturated fatty acids (SFA) and simple sugar and was low in fiber.
Other: 3 maximal aerobic tests
Maximal aerobic tests will be performed before diet intervention, after the first diet and after the second diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endocannabinoid level post physical activity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2019

Primary Completion (Actual)

November 14, 2019

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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