MCI
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTActive group
2 x 12 g of EKS/day
DIETARY_SUPPLEMENTPlacebo group
Isocaloric placebo supplement with similar salt load but no EKS
Sponsors
Alzheimer's Association
Nestle Health Science
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Investigators, participants and outcome assessors will be fully blinded.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acetoacetate brain uptake | 6 months | CMRacac measured by PET Scan |
| Glucose brain uptake | 6 months | CMRgluc measured by PET Scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognition | 0-3-6-9 months | — |
| Plasma biomarkers | 9 months | glucose, fatty acids, ketones |
| Structural and functional brain measures | 6 months | — |
Countries
Canada
Outcome results
None listed