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Completed

NCT Number: NCT02551419

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

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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Key information

Conditions

Mild Cognitive Impairment Acid-Base Imbalance Acidosis Cognition Disorders Cognitive Dysfunction Ketosis Mental Disorders Metabolic Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Center on Aging

Sherbrooke, Quebec, J1H 4C4, Canada

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

ketogenic drink

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

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Alzheimer's Association

Registry information

Official study title

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

Acronym: BENEFIC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2015
Registry last updated
Mar 26, 2020

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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