ExerciseNCT05226962
The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists
A study testing Ketone monoester in people with Exercise and Ketosis, run by McMaster University at 1 site in Canada.
Trial summary
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 time trial performance. Participants will perform two trials in a randomized order. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Ketone monoester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Habitually ingesting >50 g of dietary carbohydrate daily i.e. not following a ketogenic diet.
- Regularly performing cycling exercise at least 3 days per week and for a total of ≥5 hours per week.
- Having an estimated peak oxygen uptake of ≥55 ml/kg/min for males and ≥48 ml/kg/min for females based on the online fitness calculator available at: www.worldfitnesslevel.org.
- Having competitive cycling experience.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 time trial performance. Participants will perform two trials in a randomized order. Each trial will involve a 20-minute bout of cycling on a stationary ergometer. Participants will ingest either 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 responses.
Read the detailed description
This study will determine if the acute ingestion of a ketone supplement alters cycling time trial performance. Trained participants with competitive cycling experience will be recruited. Exercise will involve a 20-minute bout of cycling on a stationary ergometer with the goal of producing the highest power output possible. Participants will ingest either 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 responses.
- Being tested
- Ketone monoester, Placebo
- Keywords
- Performance
- Medical subject headings
- Motor Activity, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone monoesterDietary supplement
A commercial liquid supplement ingested in a dose intended to provide ~0.35 g of ketone monoester per kg body mass of the participant
PlaceboOther
A liquid placebo that is volume- and taste-matched to the ketone monoester supplement
| Study group | Role | What they receive |
|---|---|---|
| Ketone | Active comparator | An acute bout of exercise performed after the ingestion of a commercial ketone monoester supplement. Receives: Dietary Supplement: Ketone monoester |
| Control | Placebo comparator | An acute bout of exercise performed after the ingestion of a taste-matched placebo supplement. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power output
Mean power output produced while cycling
Measured: 20-minute measurement during exercise
Secondary outcomes (4)
Heart rate
Mean heart rate while cycling
Measured: 20-minute measurement during exercise
Perceived exertion
Rating of perceived exertion while cycling
Measured: Single measurement immediately after exercise
Blood ketone
Blood ketone before exercise
Measured: Single measurement immediately prior to exercise
Blood glucose
Mean blood glucose while cycling
Measured: 20-minute measurement during exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start15 Feb 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Gibala, McMaster University
- Investigators
- Martin Gibala, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226962
- Sponsor's protocol ID
- 13837
- Status last verified
- Nov 2022
- First submitted
- 27 Jan 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists
- ClinicalTrials.gov ID
- NCT05226962
- Acronym / sponsor ID
- 13837
- Keywords
- Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 time trial performance. Participants will perform two trials in a randomized order. Each trial will involve a 20-minute bout of cycling on a stationary ergometer. Participants will ingest either 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 responses.
Detailed description
This study will determine if the acute ingestion of a ketone supplement alters cycling time trial performance. Trained participants with competitive cycling experience will be recruited. Exercise will involve a 20-minute bout of cycling on a stationary ergometer with the goal of producing the highest power output possible. Participants will ingest either 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 responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone | Active comparator | Dietary Supplement: Ketone monoesterAn acute bout of exercise performed after the ingestion of a commercial ketone monoester supplement. |
| Control | Placebo comparator | Other: PlaceboAn acute bout of exercise performed after the ingestion of a taste-matched placebo supplement. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Habitually ingesting >50 g of dietary carbohydrate daily i.e. not following a ketogenic diet.
- Regularly performing cycling exercise at least 3 days per week and for a total of ≥5 hours per week.
- Having an estimated peak oxygen uptake of ≥55 ml/kg/min for males and ≥48 ml/kg/min for females based on the online fitness calculator available at: www.worldfitnesslevel.org.
- Having competitive cycling experience.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone monoesterA commercial liquid supplement ingested in a dose intended to provide ~0.35 g of ketone monoester per kg body mass of the participant | Dietary supplement | Ketone |
| PlaceboA liquid placebo that is volume- and taste-matched to the ketone monoester supplement | Other | Control |
Primary outcome
Power output
Time frame: 20-minute measurement during exercise
Mean power output produced while cycling
4 secondary outcomes
Heart rate
Time frame: 20-minute measurement during exercise
Perceived exertion
Time frame: Single measurement immediately after exercise
Blood ketone
Time frame: Single measurement immediately prior to exercise
Blood glucose
Time frame: 20-minute measurement during exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Gibala, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone monoester in people with Exercise and Ketosis, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power output (time frame: 20-minute measurement during exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.