Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2025-03-31
2027-08-31
Brief Summary
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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.
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Detailed Description
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In total, participants will be asked to complete 5 visits. Data will be collected at a single site in Hamilton, Ontario associated with McMaster University. All interested individuals will complete an eligibility screening study visit (Visit 1) to establish inclusion/exclusion. Written, informed consent will be obtained before data collection. Demographic information and medical history will be collected at the beginning of Visit 1 to obtain information regarding medication use, medical history, age, years of education, and sex and gender-based variables. This information will be collected using a participant history questionnaire and the GENESIS-PRAXY questionnaire. Participants will also be introduced to the lab and the different tests that we will run during the experimental visits. Data will be collected at two time points for each condition: 1) Pre-intervention (Visits 2 \& 4: baseline); and post-intervention (Visits 3 \& 5: following 14-day intervention). In a randomized crossover design, participants will be randomly allocated to a condition (placebo or KME) for a 14-day intervention. Participants will then undergo a washout period, afterwhich participants will be complete the alternate condition including baseline data collection (Visit 4) and post-intervention visit (Visit 5) after the second 14-day intervention period.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Ketone monoester (KME) supplement
Participants will be instructed to consume a ketone monoester (KME) supplement prior to each meal (3x/day) for 14 days.
Ketone monoester (KME) supplement
15g of a KME supplement orally consumed 3x daily for 14 days. This dosing protocol raises plasma β-OHB consistently during the waking hours. Oral KME will be provided in opaque bottles labelled A or B to maintain condition blinding. Each bottle will contain a drink providing 15g of a KME supplement: \[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate (ΔG®, TDeltaS, Oxford, UK).
Placebo supplement
Participants will be instructed to consume a bottle of placebo supplement prior to each meal (3x/day) for 14 days.
Placebo supplement
50mL taste-match inert calorie-free placebo drink orally consumed 3x daily for 14 days. Oral placebo will be provided in opaque bottles labelled A or B to maintain condition blinding.
Interventions
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Ketone monoester (KME) supplement
15g of a KME supplement orally consumed 3x daily for 14 days. This dosing protocol raises plasma β-OHB consistently during the waking hours. Oral KME will be provided in opaque bottles labelled A or B to maintain condition blinding. Each bottle will contain a drink providing 15g of a KME supplement: \[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate (ΔG®, TDeltaS, Oxford, UK).
Placebo supplement
50mL taste-match inert calorie-free placebo drink orally consumed 3x daily for 14 days. Oral placebo will be provided in opaque bottles labelled A or B to maintain condition blinding.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* SCD will be determined using the Prospective-Retrospective Memory Questionnaire (PRMQ) following the SCD Initiative Working Group framework
Exclusion Criteria
* 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
55 Years
75 Years
ALL
No
Sponsors
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Heart and Stroke Foundation of Canada
OTHER
McMaster University
OTHER
Responsible Party
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Jeremy Walsh
Assistant Professor
Principal Investigators
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Jeremy Walsh, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University
Hamilton, Ontario, Canada
Countries
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Central Contacts
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References
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Other Identifiers
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05992572
Identifier Type: -
Identifier Source: org_study_id
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