Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease

NCT ID: NCT02709356

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

1-month of 60-40 MCT oil

Intervention Type DIETARY_SUPPLEMENT

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

1-month of C8 MCT oil

Intervention Type DIETARY_SUPPLEMENT

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

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)

Group Type EXPERIMENTAL

1-month of 60-40 MCT oil

Intervention Type DIETARY_SUPPLEMENT

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

1-month of C8 MCT oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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1-month of 60-40 MCT oil

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

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Vitae

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Cunnane, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2016-547

Identifier Type: -

Identifier Source: org_study_id

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