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

Primary Purpose

Diet Habit, Microbial Colonization, Activity, Motor

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

3 maximal aerobic tests

About this trial

This is an interventional basic science trial for Diet Habit focused on measuring Microbiome, Endocannabinoids

Eligibility Criteria

20 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Institut sur la nutrition et les aliments fonctionnels

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Mediterannen diet

Canadian diet

Arm Description

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.

The NAM diet had a high content in saturated fatty acids (SFA) and simple sugar and was low in fiber.

Outcomes

Primary Outcome Measures

Endocannabinoid level post physical activity

Secondary Outcome Measures

Full Information

NCT ID

NCT04766528

First Posted

February 19, 2021

Last Updated

February 19, 2021

Sponsor

Laval University

1. Study Identification

Unique Protocol Identification Number

NCT04766528

Brief Title

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

Acronym

PerOME

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 6, 2019 (Actual)

Primary Completion Date

November 14, 2019 (Actual)

Study Completion Date

November 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diet Habit, Microbial Colonization, Activity, Motor

Keywords

Microbiome, Endocannabinoids

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mediterannen diet

Arm Type

Experimental

Arm Description

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.

Arm Title

Canadian diet

Arm Type

Experimental

Arm Description

The NAM diet had a high content in saturated fatty acids (SFA) and simple sugar and was low in fiber.

Intervention Type

Other

Intervention Name(s)

3 maximal aerobic tests

Intervention Description

Maximal aerobic tests will be performed before diet intervention, after the first diet and after the second diet

Primary Outcome Measure Information:

Title

Endocannabinoid level post physical activity

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Institut sur la nutrition et les aliments fonctionnels

City

Québec

ZIP/Postal Code

G1V0A6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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