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

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ClinicalTrials.gov Identifier: NCT02551419
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Université de Sherbrooke

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dietary Supplement: ketogenic drink Dietary Supplement: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of a Ketogenic Supplement on Brain Energy Metabolism Measured by Neuroimaging in Mild Cognitive Impairment
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. regional brain volumes by vMRI [ Time Frame: Baseline and 6 months of intervention ]
    Change in brain volume measure by MRI

  4. 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)

  5. Change in cognitive status- language domain [ Time Frame: Baseline and 6 months of intervention ]
    Change in language assessed by Boston Naming Test (Z score)

  6. 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)

  7. 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)

  8. Blood metabolite profile triglycerides [ Time Frame: Baseline and 6 months of intervention ]
    Changes in Triglycerides (mM)

  9. Blood metabolite profile Glucose [ Time Frame: Baseline and 6 months of intervention ]
    Changes in Glucose (mM)

  10. Blood metabolite profile cholesterol [ Time Frame: Baseline and 6 months of intervention ]
    Changes in Total cholesterol (mM)

  11. 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)

  12. Pharmacokinetic ketone response (phase 2) [ Time Frame: Baseline and 6 months of intervention ]
    Area under the curve of pharmacokinetic of blood ketone


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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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): NCT02551419


Locations
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Canada, Quebec
Research Center on Aging
Sherbrooke, Quebec, Canada, J1H 4C4
Sponsors and Collaborators
Université de Sherbrooke
Alzheimer's Association
Investigators
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Principal Investigator: Stephen Cunnane, Ph.D. Université de Sherbrooke
  Study Documents (Full-Text)

Documents provided by Université de Sherbrooke:
Statistical Analysis Plan  [PDF] November 28, 2019

More Information
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Publications:

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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02551419    
Other Study ID Numbers: 2015-509
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: November 2019
Keywords provided by Université de Sherbrooke:
mild cognitive impairment
ketones
medium chain triglycerides
Positron emission tomography
 magnetic resonance imaging
cognition
brain
neuroimaging
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders