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Ketone Supplements for Cerebral Health (kCBF Trial)

N/A
Recruiting
Led By Jeremy J Walsh, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 18 and 35
Be between 18 and 65 years old
Must not have
Presence of obesity (body mass index > 30 kg/m^2)
History of cardiovascular events requiring hospitalization (i.e., heart attack)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-hour, then during submaximal exercise (performed after 2-hour rest period)
Awards & highlights

Summary

This trial aims to find out if taking oral ketone supplements can improve cognition, cerebral blood flow, and exercise performance.

Who is the study for?
This trial is for young adults aged 18 to 35 who are generally healthy. It's not suitable for individuals with obesity, type 2 diabetes, a history of serious heart conditions or concussions with ongoing symptoms, or those currently on a ketogenic diet or taking ketone supplements.Check my eligibility
What is being tested?
The study tests the effects of two different doses of an oral ketone supplement on brain blood flow and thinking skills in young adults. Participants will receive either a placebo, low dose β-OHB (a type of ketone), or high dose β-OHB to see how these affect their bodies and minds.See study design
What are the potential side effects?
Potential side effects may include changes in blood acidity which could impact exercise performance if taken shortly before physical activity. Other side effects are not specified but could relate to typical reactions from dietary supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My BMI is over 30, indicating obesity.
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I have been hospitalized for a heart attack before.
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I am on a ketogenic diet or taking ketone supplements.
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I have type 2 diabetes.
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I have had a concussion and still experience symptoms.
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I have a known heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-hour, then during submaximal exercise (performed after 2-hour rest period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-hour, then during submaximal exercise (performed after 2-hour rest period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Resting cerebral blood flow (CBF)
Secondary outcome measures
Brain-derived neurotrophic factor (BDNF)
Cognitive Function
End-tidal CO2
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose β-OHBExperimental Treatment1 Intervention
Single dose of a ketone monoester ([R]-3-hydroxybutyl [R]-3-hydroxybutyrate; 0.3 g β-OHB/kg body weight)
Group II: High Dose β-OHBExperimental Treatment1 Intervention
Single dose of a ketone monoester ([R]-3-hydroxybutyl [R]-3-hydroxybutyrate; 0.6 g β-OHB/kg body weight)
Group III: PlaceboPlacebo Group1 Intervention
Single dose of a taste-matched calorie-free placebo

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Who is running the clinical trial?

McMaster UniversityLead Sponsor
896 Previous Clinical Trials
2,610,210 Total Patients Enrolled
1 Trials studying Cognition
30 Patients Enrolled for Cognition
Jeremy J Walsh, PhDPrincipal InvestigatorMcMaster University
1 Previous Clinical Trials
20 Total Patients Enrolled
~12 spots leftby Jul 2025
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