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Completed

NCT Number: NCT02709356

Medium Chain Triglycerides and Brain Metabolism in 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Sherbrooke, Quebec, J1H4C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

1-month of 60-40 MCT oil

Dietary Supplement

1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day

1-month of C8 MCT oil

Dietary Supplement

1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Fondation Vitae

Registry information

Official study title

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

Acronym: MCT-MA

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2016
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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