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

March 24, 2020 updated by: Université de Sherbrooke

Effect of a Ketogenic Supplement on Brain Energy Metabolism Measured by Neuroimaging in Mild Cognitive Impairment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

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, J1H 4C4
        • Research Center on Aging

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: 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.
Placebo Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in global ketone (11C-AcAc) uptake in grey matter
Time Frame: Baseline and 6 months of intervention
The change in brain ketone uptake will be quantified by PET and expressed as cerebral metabolic rate of AcAc (CMR-A)
Baseline and 6 months of intervention
Change in plasma ketone
Time Frame: Baseline and 6 months of intervention
The change in plasma ketone will be measure to obtain a ketone chronic response
Baseline and 6 months of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in global brain FDG uptake in grey matter (CMR-G)
Time Frame: Baseline and 6 months of intervention
The change in brain glucose uptake will be quantified by PET and expressed as cerebral metabolic rate of glucose (CMR-G)
Baseline and 6 months of intervention
Change in regional CMR-A
Time Frame: Baseline and 6 months of intervention
The change in brain ketone uptake will be quantified by PET in different regions of the brain
Baseline and 6 months of intervention
regional brain volumes by vMRI
Time Frame: Baseline and 6 months of intervention
Change in brain volume measure by MRI
Baseline and 6 months of intervention
Change in cognitive status - episodic memory
Time Frame: Baseline and 6 months of intervention
Change in episodic memory assessed by the 16-item free/cued word learning (Buschke and Grober test- Z score of trial 1, 2, 3 and delay) and the Brief Visuospatial Memory Test-revised (Z score of trial 1)
Baseline and 6 months of intervention
Change in cognitive status- language domain
Time Frame: Baseline and 6 months of intervention
Change in language assessed by Boston Naming Test (Z score)
Baseline and 6 months of intervention
Change in cognitive status - executive function
Time Frame: Baseline and 6 months of intervention
Change in executive function assessed by condition 4 of the trail making test, condition 3 and 4 of the Stroop test and the 4 conditions of verbal fluency test (all Z score)
Baseline and 6 months of intervention
Change in cognitive status - processing speed
Time Frame: Baseline and 6 months of intervention
Change in processing speed assessed by global score of Digit Span (WAIS III), Digit Symbol (WAIS III), condition 1 and 2 of Stroop test and condition 1,2,3,5 of the trail making test (all Z score)
Baseline and 6 months of intervention
Blood metabolite profile triglycerides
Time Frame: Baseline and 6 months of intervention
Changes in Triglycerides (mM)
Baseline and 6 months of intervention
Blood metabolite profile Glucose
Time Frame: Baseline and 6 months of intervention
Changes in Glucose (mM)
Baseline and 6 months of intervention
Blood metabolite profile cholesterol
Time Frame: Baseline and 6 months of intervention
Changes in Total cholesterol (mM)
Baseline and 6 months of intervention
Derived cerebral metabolic rate of total ketones
Time Frame: Baseline and 6 months of intervention
Cerebral metabolic rate of total ketone derived from ketone PET (dCMRket, μmol/100 g/min)
Baseline and 6 months of intervention
Pharmacokinetic ketone response (phase 2)
Time Frame: Baseline and 6 months of intervention
Area under the curve of pharmacokinetic of blood ketone
Baseline and 6 months of intervention

Collaborators and Investigators

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

Sponsor

Université de Sherbrooke

Collaborators

Alzheimer's Association

Investigators

  • Principal Investigator: Stephen Cunnane, Ph.D., Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-509

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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