Back to resultsMedium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease (MCT-MA)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
1-month of 60-40 MCT oil
1-month of C8 MCT oil
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Good general health for Control group
- Diagnosis of Alzheimer's disease (NINCDS-ADRDA criteria) for AD group
Exclusion Criteria:
- Depression
- Medical or psychiatric conditions that could interfere with study participation
- Fasting plasma glucose ≥7.0 mM (diabetes or prediabetes)
- Already on MCT supplementation
- Clinically-significant gastrointestinal disease/conditions
- Clinically-significant liver disease/dysfunction
- Clinically-significant renal disease/dysfunction
- Clinically-significant cardiac disease/conditions
- Hypertension
- Uncontrolled dyslipidaemia
- Vitamin B12 deficiency
- Structured physical activity (more than 3 times/week)
Sites / Locations
- Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Alzheimer's disease
Controls
Arm Description
Patients with mild Alzheimer's disease. 1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
Healthy elderly people 1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
Outcomes
Primary Outcome Measures
Quantification of brain glucose uptake
Brain glucose uptake (umol/100g/min) using 18-FDG PET scan
Quantification of brain acetoacetate uptake
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan
Secondary Outcome Measures
Full Information
NCT ID
NCT02709356
First Posted
February 1, 2016
Last Updated
October 9, 2018
Sponsor
Université de Sherbrooke
Collaborators
Fondation Vitae
1. Study Identification
Unique Protocol Identification Number
NCT02709356
Brief Title
Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease
Acronym
MCT-MA
Official Title
Proof of Concepts: Can a Supplement Ketogenic Based MCT Oil Increases Cerebral Capture Ketones in People With Alzheimer's Disease?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Fondation Vitae
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate and compare the changes in brain ketone and glucose uptake after taking two different MCT oil emulsions (60-40 oil or C8 oil) for one month, in a group of people with Alzheimer's disease and a control group.
Detailed Description
Based on a PET/MRI protocol, the aim of this study is to evaluate and compare the response to the dietary supplementation of two different MCT oils (60% C10 + 40% C8 or 100 % C8) in two groups, patients with Alzheimer's disease and healthy elderly people (N=10/group). After a baseline evaluation, participant will test one of the supplements during two successive periods of one month; each period of time ending with 18F-FDG and 11C-acetoacetate PET scans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alzheimer's disease
Arm Type
Experimental
Arm Description
Patients with mild Alzheimer's disease.
1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
Arm Title
Controls
Arm Type
Experimental
Arm Description
Healthy elderly people
1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
Intervention Type
Dietary Supplement
Intervention Name(s)
1-month of 60-40 MCT oil
Intervention Description
1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day
Intervention Type
Dietary Supplement
Intervention Name(s)
1-month of C8 MCT oil
Intervention Description
1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)
Primary Outcome Measure Information:
Title
Quantification of brain glucose uptake
Description
Brain glucose uptake (umol/100g/min) using 18-FDG PET scan
Time Frame
1-month
Title
Quantification of brain acetoacetate uptake
Description
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan
Time Frame
1-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good general health for Control group
Diagnosis of Alzheimer's disease (NINCDS-ADRDA criteria) for AD group
Exclusion Criteria:
Depression
Medical or psychiatric conditions that could interfere with study participation
Fasting plasma glucose ≥7.0 mM (diabetes or prediabetes)
Already on MCT supplementation
Clinically-significant gastrointestinal disease/conditions
Clinically-significant liver disease/dysfunction
Clinically-significant renal disease/dysfunction
Clinically-significant cardiac disease/conditions
Hypertension
Uncontrolled dyslipidaemia
Vitamin B12 deficiency
Structured physical activity (more than 3 times/week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Cunnane, PhD
Organizational Affiliation
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) - Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H4C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease
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