NCT04766528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
Last Updated

February 23, 2021

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

February 19, 2021

Last Update Submit

February 19, 2021

Conditions

Diet HabitMicrobial ColonizationActivity, Motor

Keywords

MicrobiomeEndocannabinoids

Outcome Measures

Primary Outcomes (1)

  • Endocannabinoid level post physical activity

    6 months

Study Arms (2)

Mediterannen diet

EXPERIMENTAL

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

Canadian diet

EXPERIMENTAL

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

Interventions

3 maximal aerobic testsOTHER

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

Canadian dietMediterannen diet

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut sur la nutrition et les aliments fonctionnels

Québec, G1V0A6, Canada

Location

MeSH Terms

Conditions

Feeding BehaviorCommunicable DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 23, 2021

Study Start

September 6, 2019

Primary Completion

November 14, 2019

Study Completion

November 14, 2019

Last Updated

February 23, 2021

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)