BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

Study Overview
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Brief Summary
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A six month randomized controlled intervention with an exogenous ketone salt (EKS) supplement in mild cognitive impairment. Participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of EKS). Outcomes: brain energy metabolism, cognition, plasma biomarkers, brain imaging (volumetric, functional, structural) and quality of life will be analyzed before and after the intervention.

Official Title
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6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment

Conditions
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MCI

Intervention / Treatment
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* Dietary Supplement: Active group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant must answer Yes to the question ''Do you think your memory is not as good as it was?'' Have a MoCA Score between 20/30 and 26/30 Have a QAF score of less than 9/30 Understand, read and talk French Having good visual and hearing acuity Exclusion Criteria: Major cognitive decline or neurodegenerative disease. Already consuming a daily medium chain triglyceride or ketone supplement. Soy, milk, gluten or allergy to the study product Controlled or uncontrolled diabetes Uncontrolled chronic disease Vitamin B12 deficit Clinical anomaly in the blood chemistry profile QSP-9 score over 19/27 Taking an anti-cholinergic drugs Recent change in medication Active cancer in the last 2 years General anesthesia in the last 6 months history of alcohol abuse or dependence in the last 2 years Participation in other interventional or PET research project Unable to undergo an MRI or PET scan History of kidney stones or hypercalcemia History of cardiovascular events or insufficiency Renal failure and / or creatinine <58 umol or> 110 umol for men and <46 umol or> 92 umol for women or if the GFR (glomerular filtration rate) <60 ml / min / 1.73 m2 Chronic disease of the digestive system or intestinal malabsorption (celiac disease, chronic pancreatitis, Crohn's disease, etc.) Body mass index <20 or voluntary weight loss of more than 5% in the last 6 months.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial. First phase :Two parallel groups, one placebo, one active Second phase : All participants will be invited to take part in an open phase on the active product only.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active group<br>Participants will be on the active intervention for 6 months | Dietary Supplement: Active group<br>* 2 x 12 g of EKS/day<br>|
| Placebo Comparator: Placebo Group<br>Participants will be on the placebo intervention for 6 months | Dietary Supplement: Placebo group<br>* Isocaloric placebo supplement with similar salt load but no EKS<br>|
| Active Comparator: Open phase on active product<br>At the end of the 6-month randomized controlled phase, participants will be unblinded and invited to continue on the active product for an additional 3 months. | Dietary Supplement: Active group<br>* 2 x 12 g of EKS/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetoacetate brain uptake | CMRacac measured by PET Scan | 6 months | 
| Glucose brain uptake | CMRgluc measured by PET Scan | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition |  | 0-3-6-9 months | 
| Plasma biomarkers | glucose, fatty acids, ketones | 9 months | 
| Structural and functional brain measures |  | 6 months |