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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
82
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.
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
Research Center on Aging
Sherbrooke, Quebec, Canada
Change in global ketone (11C-AcAc) uptake in grey matter
The change in brain ketone uptake will be quantified by PET and expressed as cerebral metabolic rate of AcAc (CMR-A)
Time frame: Baseline and 6 months of intervention
Change in plasma ketone
The change in plasma ketone will be measure to obtain a ketone chronic response
Time frame: Baseline and 6 months of intervention
Change in global brain FDG uptake in grey matter (CMR-G)
The change in brain glucose uptake will be quantified by PET and expressed as cerebral metabolic rate of glucose (CMR-G)
Time frame: Baseline and 6 months of intervention
Change in regional CMR-A
The change in brain ketone uptake will be quantified by PET in different regions of the brain
Time frame: Baseline and 6 months of intervention
regional brain volumes by vMRI
Change in brain volume measure by MRI
Time frame: Baseline and 6 months of intervention
Change in cognitive status - episodic memory
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)
Time frame: Baseline and 6 months of intervention
Change in cognitive status- language domain
Change in language assessed by Boston Naming Test (Z score)
Time frame: Baseline and 6 months of intervention
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Change in cognitive status - executive function
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)
Time frame: Baseline and 6 months of intervention
Change in cognitive status - processing speed
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)
Time frame: Baseline and 6 months of intervention
Blood metabolite profile triglycerides
Changes in Triglycerides (mM)
Time frame: Baseline and 6 months of intervention
Blood metabolite profile Glucose
Changes in Glucose (mM)
Time frame: Baseline and 6 months of intervention
Blood metabolite profile cholesterol
Changes in Total cholesterol (mM)
Time frame: Baseline and 6 months of intervention
Derived cerebral metabolic rate of total ketones
Cerebral metabolic rate of total ketone derived from ketone PET (dCMRket, μmol/100 g/min)
Time frame: Baseline and 6 months of intervention
Pharmacokinetic ketone response (phase 2)
Area under the curve of pharmacokinetic of blood ketone
Time frame: Baseline and 6 months of intervention