BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

Phase 2

Recruiting

• Conditions: MCI
• Interventions: Dietary Supplement: Active group; Dietary Supplement: Placebo group

• Registration Number: NCT04466735
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Study Start: 2020-10-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open phase on active product	Active group	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.
Placebo Group	Placebo group	Participants will be on the placebo intervention for 6 months
Active group	Active group	Participants will be on the active intervention for 6 months

Primary Outcome Measures

Name	Time	Method
Acetoacetate brain uptake	6 months	CMRacac measured by PET Scan
Glucose brain uptake	6 months	CMRgluc measured by PET Scan

Secondary Outcome Measures

Name	Time	Method
Plasma biomarkers	9 months	glucose, fatty acids, ketones
Cognition	0-3-6-9 months
Structural and functional brain measures	6 months

Trial Locations

Locations (1)

Rearsh Centre on Aging; 🇨🇦 Sherbrooke, Quebec, Canada