Ketone higher dose for Ketosis

McMaster University, Hamilton, Canada
Ketosis+1 More ConditionsKetone monoester - DietarySupplement
Eligibility
18 - 60
All Sexes

Study Summary

This trial will study how ketone supplements affect exercise efficiency by having participants take the supplement prior to exercise and testing their metabolic responses.

Eligible Conditions
  • Ketosis
  • Exercise

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Measurement made immediately prior to exercise

Continuous measurement made over each of three, 5-minute consecutive stages of an incremental cycle exercise test at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity
Exercise efficiency
Heart rate
Measurement made at the end of each of three, 5-minute consecutive stages of an incremental cycle exercise test at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity
Rating of perceived exertion
Measurement made immediately prior to exercise
Ketone body content in venous blood

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

3 Treatment Groups

Ketone higher dose
1 of 3
Ketone lower dose
1 of 3
Control
1 of 3

Experimental Treatment

Non-Treatment Group

30 Total Participants · 3 Treatment Groups

Primary Treatment: Ketone higher dose · Has Placebo Group · N/A

Ketone higher dose
DietarySupplement
Experimental Group · 1 Intervention: Ketone monoester · Intervention Types: DietarySupplement
Ketone lower dose
DietarySupplement
Experimental Group · 1 Intervention: Ketone monoester · Intervention Types: DietarySupplement
Control
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketone monoester
2022
Completed Phase 1
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measurement made immediately prior to exercise

Who is running the clinical trial?

McMaster UniversityLead Sponsor
835 Previous Clinical Trials
2,632,790 Total Patients Enrolled
1 Trials studying Ketosis
25 Patients Enrolled for Ketosis
Martin J Gibala, PhDPrincipal InvestigatorMcMaster University

Eligibility Criteria

Age 18 - 60 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You participate in more than three hours of endurance exercise per week.

Frequently Asked Questions

Are elderly participants being engaged in the research endeavor?

"The eligibility criteria for this medical experiment requires participants to be aged between 18 and 60." - Anonymous Online Contributor

Unverified Answer

Who qualifies to join this research program?

"To be approved for this medical trial, patients must have ketosis and are restricted to ages 18-60. This research effort is accepting approximately 30 individuals." - Anonymous Online Contributor

Unverified Answer

Does this research endeavor have any new participants joining at the moment?

"Per the information made available on clinicaltrials.gov, this investigation is actively accepting participants. It was first posted at the end of December 2022 and has been most recently edited in April 2023." - Anonymous Online Contributor

Unverified Answer

How many subjects are participating in this investigation?

"Affirmative. Clinicaltrials.gov reveals that recruitment is currently underway for this medical trial, which began on December 27th 2022 and was recently updated on April 4th 2023. A total of 30 patients are needed at a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.