Proof of Mechanism of a New Ketogenic Supplement Using Dual Tracer PET (Positron Emission Tomography)

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-12-31

Brief Summary

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A six month, placebo-controlled, parallel group project in which MCI participants will receive 30 g/day of a custom-made MCT-based ketogenic supplement or a matching placebo. Uptake of both the brain's fuels - ketones (as 11C-AcAc) and glucose (as FDG) - both before and after the intervention will be assessed by PET (position emission tomography) ; imaging and ketone pharmacokinetic as primary objective as well as fMRI, diffusion MRI and cognition.

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Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketogenic drink

MCT ketogenic drink: ketogenic drink providing 30 g/d of MCT oil in 250 ml of lactose-free skim milk for 6 months supplementation

Group Type EXPERIMENTAL

ketogenic drink

Intervention Type DIETARY_SUPPLEMENT

6 months' supplementation with the ketogenic drink . Product will be taken daily - 125 ml will be consumed at the morning meal, and 125 ml at the evening meal.

Placebo

Lactose-free skim milk-based placebo drink containing high-oleic sunflower oil of equivalent energy value to the active arm for a 6 months supplementation

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

6 months' supplementation with the placebo drink . Product will be taken daily - 125 ml will be consumed at the morning meal, and 125 ml at the

Interventions

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ketogenic drink

6 months' supplementation with the ketogenic drink . Product will be taken daily - 125 ml will be consumed at the morning meal, and 125 ml at the evening meal.

Intervention Type DIETARY_SUPPLEMENT

placebo

6 months' supplementation with the placebo drink . Product will be taken daily - 125 ml will be consumed at the morning meal, and 125 ml at the

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* subjective memory complaint
* Montreal Cognitive Assessment (MoCA) score of 18-26/30 or a Mini-mental state exam (MMSE) score of 24-27/30
* autonomy for activity of daily living
* absence of depression

Exclusion Criteria

* diagnosis of a major cognitive disorder
* diseases or psychiatric disorders that could interfere with participation
* uncontrolled diabetes (fasting plasma glucose \>7 mM or glycated hemoglobin \>6.5%)
* major depression or history of alcohol or substance abuse within the past 2 years,
* already supplementing with coconut oil or MCT
* vitamin B12 deficiency
* uncontrolled hypertension, dyslipidemia, or thyroid disease,
* visual or hearing impairment impeding comprehension
* participation in another intervention trial
* inability to lie down without moving for 60 min (for the brain imaging)
* presence of implanted metal objects or devices contraindicated for MRI (phase 1)

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No