- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665855
The Effects of Acute Ketone Monoester Supplementation on Exercise Efficiency and the Influence of Dose and Intensity
July 7, 2023 updated by: Martin Gibala, McMaster University
Diet can alter blood ketone levels and this in turn may affect exercise capacity.
This study will determine if the acute ingestion of a ketone supplement alters cycling exercise efficiency.
Participants will perform three trials in a randomized order.
Each trial will involve an incremental exercise protocol on a stationary cycle ergometer to volitional fatigue.
Participants will ingest either a high or low dose of a ketone supplement or a taste-matched placebo drink prior to exercise.
Blood samples will be obtained to assess selected metabolic responses.
This study will provide information regarding the effect of ketone supplementation on exercise efficiency.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study will determine if the acute ingestion of a ketone supplement alters cycling exercise efficiency.
Trained participants with cycling experience will be recruited.
Participants will perform three trials in a randomized order.
Each trial will involve a 3-minute warm-up followed by an incremental ramp test.
The ramp will initially consist of three, 5-minute stages performed at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity.
This will be followed by a further incremental ramp test to volitional fatigue.
Participants will ingest either a high or low dose of a ketone supplement or a taste-matched placebo drink prior to exercise using a randomized, double-blind crossover design.
Diet prior to exercise will be standardized between trials for a given participant.
Blood samples will be obtained to assess selected metabolic responses.
This study will provide information regarding the effect of ketone supplementation on exercise efficiency.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S4K1
- McMaster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be habitually consuming ≥50 g/d of carbohydrate (i.e., not following a ketogenic diet).
- Be engaged in endurance-type exercise >3h/wk.
- Have an estimated VO2peak of ≥90% for age and sex as estimated by an online calculator found at www.worldfitnesslevel.org.
Exclusion Criteria:
- Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the Canadian Society for Exercise Physiology Get Active Questionnaire.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ketone higher dose
An acute bout of exercise performed after the ingestion of a commercial supplement intended to provide ~0.6 g of ketone monoester per kg body mass of the participant.
|
A commercial liquid ketone monoester supplement.
|
|
Experimental: Ketone lower dose
An acute bout of exercise performed after the ingestion of a commercial supplement intended to provide ~0.3 g of ketone monoester per kg body mass of the participant.
|
A commercial liquid ketone monoester supplement.
|
|
Placebo Comparator: Control
An acute bout of exercise performed after the ingestion of a taste-matched placebo supplement.
|
A liquid placebo that is taste-matched to the ketone monoester supplement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise efficiency
Time Frame: 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
|
Power output expressed relative to pulmonary oxygen uptake to determine cycling economy in watt per litre of oxygen per minute
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: 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
|
Mean heart rate
|
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
|
|
Rating of perceived exertion
Time Frame: 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 measured using a 6-20 scale
|
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
|
|
Ketone body content in venous blood
Time Frame: Measurement made immediately prior to exercise
|
Mixed venous blood content of the ketone body beta-hydroxybutyrate
|
Measurement made immediately prior to exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin J Gibala, PhD, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 27, 2022
Primary Completion (Actual)
May 31, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
November 17, 2022
First Submitted That Met QC Criteria
December 17, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 10, 2023
Last Update Submitted That Met QC Criteria
July 7, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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