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

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ClinicalTrials.gov Identifier: NCT02709356
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Fondation Vitae
Information provided by (Responsible Party):
Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dietary Supplement: 1-month of 60-40 MCT oil Dietary Supplement: 1-month of C8 MCT oil Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Proof of Concepts: Can a Supplement Ketogenic Based MCT Oil Increases Cerebral Capture Ketones in People With Alzheimer's Disease?
Actual Study Start Date : October 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Quantification of brain glucose uptake [ Time Frame: 1-month ]
    Brain glucose uptake (umol/100g/min) using 18-FDG PET scan

  2. Quantification of brain acetoacetate uptake [ Time Frame: 1-month ]
    Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709356


Locations
Canada, Quebec
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, Canada, J1H4C4
Sponsors and Collaborators
Université de Sherbrooke
Fondation Vitae
Investigators
Principal Investigator: Stephen Cunnane, PhD Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) - Université de Sherbrooke

Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02709356     History of Changes
Other Study ID Numbers: 2016-547
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders