Diet HabitPerOMENCT04766528
Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity
A study testing 3 maximal aerobic tests in people with Diet Habit and Microbial Colonization, run by Laval University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Habit, Microbial Colonization, Activity, Motor
- What is being tested?
- 3 maximal aerobic tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 6 Sep 2019to 14 Nov 2019
- Phase
- Interventional
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- 20-30 years old
- healthy
- jogging >1h/week and >3h/week of physical activity
- bmi 18.5-25
Who cannot join
- 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
Show all 9Show fewer
- antibiotics in the last 3 months
- night worker
- pathologies
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut sur la nutrition et les aliments fonctionnels
Québec, G1V0A6
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Habit, Microbial Colonization, Activity, Motor
- Being tested
- 3 maximal aerobic tests
- Keywords
- Microbiome, Endocannabinoids
- Medical subject headings
- Feeding Behavior, Communicable Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 maximal aerobic testsOther
Maximal aerobic tests will be performed before diet intervention, after the first diet and after the second diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 3 maximal aerobic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocannabinoid level post physical activity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start6 Sep 2019
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766528
- Sponsor's protocol ID
- 2019-005
- Acronym
- PerOME
- Status last verified
- Oct 2019
- First submitted
- 19 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Composition on the Gut Microbiota / Endocannabinoidome Axis in Response to Maximal Aerobic Exercise
- ClinicalTrials.gov ID
- NCT04766528
- Acronym / sponsor ID
- PerOME / 2019-005
- Conditions
- Diet Habit, Microbial Colonization, Activity, Motor
- Keywords
- Microbiome, Endocannabinoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 23 Feb 2021 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterannen diet | Experimental | Other: 3 maximal aerobic testsThe 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. |
| Canadian diet | Experimental | Other: 3 maximal aerobic testsThe NAM diet had a high content in saturated fatty acids (SFA) and simple sugar and was low in fiber. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women
- 20-30 years old
- healthy
- jogging >1h/week and >3h/week of physical activity
- bmi 18.5-25
Key exclusion criteria (9 listed)
- postmenopausal, pregnancy or lactation
- pathology or medication
- smoking
- more than 7 alcohol consumption/week
- food allergy, food intolerance or food aversion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 maximal aerobic testsMaximal aerobic tests will be performed before diet intervention, after the first diet and after the second diet | Other | Canadian diet, Mediterannen diet |
Primary outcome
Endocannabinoid level post physical activity
Time frame: 6 months
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 23 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 maximal aerobic tests in people with Diet Habit and Microbial Colonization, 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 5 inclusion and 9 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 23 Feb 2021. 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?
Endocannabinoid level post physical activity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2021.