Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease
MCT-MA
Proof of Concepts: Can a Supplement Ketogenic Based MCT Oil Increases Cerebral Capture Ketones in People With Alzheimer's Disease?
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedOctober 10, 2018
December 1, 2017
2.3 years
February 1, 2016
October 9, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Quantification of brain glucose uptake
Brain glucose uptake (umol/100g/min) using 18-FDG PET scan
1-month
Quantification of brain acetoacetate uptake
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan
1-month
Study Arms (2)
Alzheimer's disease
EXPERIMENTALPatients 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)
Controls
EXPERIMENTALHealthy elderly people 1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
Interventions
1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day
1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)
Eligibility Criteria
You may qualify if:
- Good general health for Control group
- Diagnosis of Alzheimer's disease (NINCDS-ADRDA criteria) for AD group
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Université de Sherbrookelead
- Fondation Vitaecollaborator
Study Sites (1)
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, J1H4C4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Cunnane, PhD
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) - Université de Sherbrooke
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2016
First Posted
March 16, 2016
Study Start
October 1, 2015
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
October 10, 2018
Record last verified: 2017-12