Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease (MCT-MA)

October 9, 2018 updated by: Université de Sherbrooke

Proof of Concepts: Can a Supplement Ketogenic Based MCT Oil Increases Cerebral Capture Ketones in People With Alzheimer's Disease?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H4C4
        • Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

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

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alzheimer's disease

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)
Dietary supplement: 1-month of 60-40 MCT oil
1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day
Dietary supplement: 1-month of C8 MCT oil
1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)
Experimental: Controls

Healthy elderly people

1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
Dietary supplement: 1-month of 60-40 MCT oil
1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day
Dietary supplement: 1-month of C8 MCT oil
1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of brain glucose uptake
Time Frame: 1-month
Brain glucose uptake (umol/100g/min) using 18-FDG PET scan
1-month
Quantification of brain acetoacetate uptake
Time Frame: 1-month
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan
1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Fondation Vitae

Investigators

  • Principal Investigator: Stephen Cunnane, PhD, Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) - 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)

October 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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