Clinical trial NCT04466735: BRain Energy Activation With Ketones to Prevent Alzheimer's Disease
Official title: 6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MCI
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: Nestle Health Science
First posted: 2020-07-10
Enrollment: 65
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acetoacetate brain uptake
timeFrame: 6 months
measure: Glucose brain uptake
timeFrame: 6 months
Secondary outcomes:
measure: Cognition
timeFrame: 0-3-6-9 months
measure: Plasma biomarkers
timeFrame: 9 months
measure: Structural and functional brain measures
timeFrame: 6 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Rearsh Centre on Aging
state: Quebec
Study officials:
References: