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Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population (PARKA)

Primary Purpose

Parkinson Disease, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Betaquik MCT supplement
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Alzheimer, Parkinson, Ketones, medium chain triglycerides, cognition, brain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre de recherche sur le vieillissementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Parkinson disease

Alzheimer's disease

Arm Description

2 months intervention with 50g/day of a commercial MCT supplement combine with supervised aerobic exercise 3x/week.

2 months intervention with 50g/day of a commercial MCT supplement combine with supervised aerobic exercise 3x/week.

Outcomes

Primary Outcome Measures

Cognition
Measure of cognition with CANTAB
Ketones
Measurement of ketones concentrations

Secondary Outcome Measures

Endocannabinoids
Endocannabinoids plasma concentration

Full Information

First Posted
March 24, 2020
Last Updated
July 18, 2023
Sponsor
Université de Sherbrooke
Collaborators
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT04322461
Brief Title
Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population
Acronym
PARKA
Official Title
Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKA
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Société des Produits Nestlé (SPN)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Alzheimer Disease
Keywords
Alzheimer, Parkinson, Ketones, medium chain triglycerides, cognition, brain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parkinson disease
Arm Type
Experimental
Arm Description
2 months intervention with 50g/day of a commercial MCT supplement combine with supervised aerobic exercise 3x/week.
Arm Title
Alzheimer's disease
Arm Type
Experimental
Arm Description
2 months intervention with 50g/day of a commercial MCT supplement combine with supervised aerobic exercise 3x/week.
Intervention Type
Dietary Supplement
Intervention Name(s)
Betaquik MCT supplement
Intervention Description
50g/day divided in 3. Breakfast, lunch and dinner
Primary Outcome Measure Information:
Title
Cognition
Description
Measure of cognition with CANTAB
Time Frame
2 months, evaluation before and after intervention
Title
Ketones
Description
Measurement of ketones concentrations
Time Frame
2 months, evaluation before and after intervention
Secondary Outcome Measure Information:
Title
Endocannabinoids
Description
Endocannabinoids plasma concentration
Time Frame
2 months, evaluation before and after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie St-Pierre, M.Sc.
Phone
819-780-2220
Ext
45286
Email
valerie.R.st-pierre@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie Fortier, M.Sc.
Phone
819-80-2220
Ext
45252
Email
melanie.fortier2@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Cunnane, Ph.D.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche sur le vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie St-Pierre, M.Sc
Phone
819-780-2220
Ext
45286
Email
valerie.R.st-pierre@usherbrooke.ca

12. IPD Sharing Statement

Learn more about this trial

Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population

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