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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-hour, then during submaximal exercise (performed after 2-hour rest period)

Awards & highlights

kCBF Trial 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.

kCBF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 35 years old.

kCBF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-hour, then during submaximal exercise (performed after 2-hour rest period)

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

kCBF 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,296 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still enrollment opportunities for this clinical experiment?

"As per the information available on clinicaltrials.gov, this medical trial is not accepting any new candidates at present. It was first posted in October 1st 2023 and last updated September 8th 2023. Nevertheless, there are 36 other trials that are actively recruiting participants now."

Answered by AI

Is the cut-off age for this trial under 75 years of age?

"This clinical trial is offered to patients between the ages of 18 and 35. There are other 5 trials available for those under 18, while 24 medical studies target individuals over 65 years old."

Answered by AI

Are there any eligibility requirements for volunteers in this research?

"This medical experiment requires participants to be of age and have cognitive aptitude. The study will accept a maximum of 20 individuals, aged 18-35 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketone Dose and Cerebral Blood Flow Study

2023. "Ketone Dose and Cerebral Blood Flow Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06032156.