Β-OHB Supplementation and Brain Health in Older Adults
ConditionSubjective Cognitive Decline
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-75
SponsorMcMaster University
About this trial
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 cognitive decline. We will test the hypothesis that KME supplementation will increase cerebral blood flow and improve resting-state functional connectivity in the brain compared to placebo supplementation in older adults with subjective cognitive decline.
Participants will be randomly assigned to either placebo of KME supplementation for 14 days. Following a washout period, participants will complete the alternate condition for 14 days. Outcome measures will be assessed before and after each intervention period.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Ketone monoester (KME) supplement
- Placebo supplement
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
McMaster University
Lead sponsor
Heart and Stroke Foundation of Canada
Collaborator
Source ClinicalTrials.gov