BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

MCI Clinical Trial

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Official title:

6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04466735
• Other study ID #: 2020-3448
• Status: Recruiting
• Phase: Phase 2
• Start date: October 15, 2020
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• MCI

Intervention

Dietary Supplement:
• Active group
2 x 12 g of EKS/day
• Placebo group
Isocaloric placebo supplement with similar salt load but no EKS

Locations

Country	Name	City	State
Canada	Rearsh Centre on Aging	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Alzheimer's Association, Nestle Health Science

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetoacetate brain uptake	CMRacac measured by PET Scan	6 months
Primary	Glucose brain uptake	CMRgluc measured by PET Scan	6 months
Secondary	Cognition		0-3-6-9 months
Secondary	Plasma biomarkers	glucose, fatty acids, ketones	9 months
Secondary	Structural and functional brain measures		6 months