BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

Last updated: May 30, 2024
Sponsor: Université de Sherbrooke
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo group

Active group

Clinical Study ID

NCT04466735
2020-3448
  • Ages 55-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • The participant must answer Yes to the question ''Do you think your memory is not asgood 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

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> 92umol 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

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Placebo group
Phase: 2
Study Start date:
October 15, 2020
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Rearsh Centre on Aging

    Sherbrooke, Quebec J1H4C4
    Canada

    Active - Recruiting

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