Status:
NOT_YET_RECRUITING
Β-OHB Supplementation and Brain Health in Older Adults
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
Conditions:
Subjective Cognitive Decline
Eligibility:
All Genders
55-75 years
Phase:
PHASE2
Brief Summary
The goal of this randomized placebo controlled crossover trial is investigate the effects of short-term ketone monoester (KME) supplementation to brain function in older adults with subjective cogniti...
Detailed Description
In this randomized placebo-controlled crossover double-blind designed clinical trial, 48 adults with SCD (50% female; aged 55 to 75 years old) will be allocated to a ketone monoester (KME) or placebo ...
Eligibility Criteria
Inclusion
- Being objectively cognitively normal as determined by a Montreal Cognitive Assessment (MoCA) score ≥26 with independent living and ambulating
- SCD will be determined using the Prospective-Retrospective Memory Questionnaire (PRMQ) following the SCD Initiative Working Group framework
Exclusion
- A diagnosis of mild cognitive impairment, dementia, or psychiatric and/or mood disorders (e.g., major depression)
- MoCA score \<26
- Diagnosis of cardiometabolic disease (e.g., hypertension, type 2 diabetes)
- Obesity (BMI \>30 kg/m2)
- History of heart attack or stroke
- History of smoking
- Currently following a ketogenic diet or taking ketogenic supplements
- Having MRI contraindications
- Participants with literacy, visual, hearing, and/or speech issues, as well as individuals who are not proficient in English will not be eligible for this trial
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06588946
Start Date
March 1 2025
End Date
August 1 2027
Last Update
February 26 2025
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8S 4K1