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

Université de Sherbrooke

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Dietary Supplement: placebo; Dietary Supplement: ketogenic drink

Study type: Interventional

Funder types: Other

Identifiers

NCT02551419

2015-509

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

ketogenic drink

Experimental group

Description:

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

Treatment:

Dietary Supplement: ketogenic drink

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: placebo