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
Sponsored by
About this trial
This is an interventional basic science trial for Diet Habit focused on measuring Microbiome, Endocannabinoids
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
Sites / Locations
- Institut sur la nutrition et les aliments fonctionnels
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
No
Learn more about this trial
Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity
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