BRain Energy Activation With Ketones to Prevent Alzheimer's Disease (BREAK-AD)

Université de Sherbrooke

Status: Completed

Conditions: MCI

Treatments: Dietary Supplement: Active group; Dietary Supplement: Placebo group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04466735

2020-3448

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

65 participants in 3 patient groups, including a placebo group

Active group

Experimental group

Description:

Participants will be on the active intervention for 6 months

Treatment:

Dietary Supplement: Active group

Placebo Group

Placebo Comparator group

Description:

Participants will be on the placebo intervention for 6 months

Treatment:

Dietary Supplement: Placebo group

Open phase on active product

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Active group