- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322461
Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population (PARKA)
May 28, 2025 updated by: Université de Sherbrooke
Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKA
A two months intervention in which two groups of cognitive disorders, Parkinson and Alzheimer's disease, will receive 50g/day of a commercial MCT supplement combined with supervised aerobic exercise 3 times/week.
Cognition and ketones will be assess before and after the intervention, along with endocannabinoids plasma concentrations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 4C4
- Centre de recherche sur le vieillissement
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Alzheimer's or parkinson disease diagnostic
- Stable medication associated with the disease
- Able to consent
- Presence of an accompanying person for the first and last visit.
- Ability to read and talk in French
Exclusion Criteria:
- MMSE < 20
- MCT or coconut oil supplementation
- Coconut allergy
- Cannabis, THC or CBD consumption
- Excessive alcohol consumption
- Physical activity 3x/week
- Presence of an metallic object in the body
- Impossibility to lay in dorsal decubitus for 40 minutes
- Cardiac disease
- Any uncontrolled disease that could interfer with the project.
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parkinson disease
2 months intervention with 50g/day of a commercial MCT supplement combine with supervised aerobic exercise 3x/week.
|
50g/day divided in 3. Breakfast, lunch and dinner
|
|
Experimental: Alzheimer's disease
2 months intervention with 50g/day of a commercial MCT supplement combine with supervised aerobic exercise 3x/week.
|
50g/day divided in 3. Breakfast, lunch and dinner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognition
Time Frame: 2 months, evaluation before and after intervention
|
Measure of cognition with CANTAB
|
2 months, evaluation before and after intervention
|
|
Ketones
Time Frame: 2 months, evaluation before and after intervention
|
Measurement of ketones concentrations
|
2 months, evaluation before and after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endocannabinoids
Time Frame: 2 months, evaluation before and after intervention
|
Endocannabinoids plasma concentration
|
2 months, evaluation before and after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Cunnane, Ph.D., Université de Sherbrooke
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)
May 1, 2022
Primary Completion (Actual)
May 27, 2024
Study Completion (Actual)
May 27, 2024
Study Registration Dates
First Submitted
March 24, 2020
First Submitted That Met QC Criteria
March 24, 2020
First Posted (Actual)
March 26, 2020
Study Record Updates
Last Update Posted (Actual)
June 3, 2025
Last Update Submitted That Met QC Criteria
May 28, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurocognitive Disorders
- Dementia
- Tauopathies
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Cognitive Dysfunction
- Alzheimer Disease
- Parkinson Disease
- Cognition Disorders
Other Study ID Numbers
- 2020-3436
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
product manufactured in and exported from the U.S.
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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