ExerciseNCT02825823
The Effects of Exogenous Ketones on Exercise Performance in Young Healthy Adults
A study testing Ketone Salt in people with Exercise and Ketones, run by University of British Columbia at 1 site in Canada.
Trial summary
The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance but this has not been adequately studied. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise, Ketones, Dietary Supplements
- What is being tested?
- Ketone Salt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to 1 Jun 2017
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 18-40
- Ability to understand and communicate in English to answer questionnaires and interact with the research assistant
- Physically active (defined by engaging in moderate-to-vigorous exercise at least 3 times per week, determined via validated questionnaire)
Who cannot join
- Diagnosed with diabetes or any other medical conditions that could affect metabolism.
- Diagnosed with heart disease or taking anti-hypertensive medications.
- Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
- Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
- Current consumption of ketone supplements
- Any other contraindication to vigorous exercise (identified via physical activity readiness questionnaire [PAR-Q])
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Okanagan.
Kelowna, British Columbia, V1V 1V7
About this study
The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone salts can alter fuel use during exercise and improve exercise performance.
- Conditions
- Exercise, Ketones, Dietary Supplements
- Being tested
- Ketone Salt, Placebo
- 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 SaltDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ketone Salts | Experimental | Acute dose of beta-hydroxybutyrate potassium/sodium salt (0.2g beta-hydroxybutyrate/kg, 0.01g Potassium/kg, 0.01g Sodium/kg with 1 g Steviol Glycoside and 30 ml of lemon juice per dose) Receives: Dietary Supplement: Ketone Salt |
| Placebo | Placebo comparator | Acute dose of taste-matched placebo (0.01g Potassium/kg, 0.01g Sodium/kg with 1 g Steviol Glycoside and 30 ml of lemon juice per dose) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Exchange Ratio (RER) during cycling exercise
The RER during 18 minutes of steady-state exercise
Measured: 0-18 minutes
Secondary outcomes (1)
10 km Cycling Time Trial Performance
10 km time trial performed on a stationary bicycle following 18 minutes of steady-state exercise
Measured: Following 18 minutes of steady-state exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
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 University of British ColumbiaThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825823
- Sponsor's protocol ID
- H1601260
- Status last verified
- Oct 2017
- First submitted
- 4 Jul 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exogenous Ketones on Exercise Performance in Young Healthy Adults
- ClinicalTrials.gov ID
- NCT02825823
- Acronym / sponsor ID
- H1601260
- Conditions
- Exercise, Ketones, Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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.
The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone salts can alter fuel use during exercise and improve exercise performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone Salts | Experimental | Dietary Supplement: Ketone SaltAcute dose of beta-hydroxybutyrate potassium/sodium salt (0.2g beta-hydroxybutyrate/kg, 0.01g Potassium/kg, 0.01g Sodium/kg with 1 g Steviol Glycoside and 30 ml of lemon juice per dose) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAcute dose of taste-matched placebo (0.01g Potassium/kg, 0.01g Sodium/kg with 1 g Steviol Glycoside and 30 ml of lemon juice per dose) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males aged 18-40
- Ability to understand and communicate in English to answer questionnaires and interact with the research assistant
- Physically active (defined by engaging in moderate-to-vigorous exercise at least 3 times per week, determined via validated questionnaire)
Key exclusion criteria (6 listed)
- Diagnosed with diabetes or any other medical conditions that could affect metabolism.
- Diagnosed with heart disease or taking anti-hypertensive medications.
- Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
- Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
- Current consumption of ketone supplements
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 Salt | Dietary supplement | Ketone Salts |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Respiratory Exchange Ratio (RER) during cycling exercise
Time frame: 0-18 minutes
The RER during 18 minutes of steady-state exercise
1 secondary outcome
10 km Cycling Time Trial Performance
Time frame: Following 18 minutes of steady-state 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 13 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Salt in people with Exercise and Ketones, run by University of British Columbia 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 3 inclusion and 6 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 13 Oct 2017. 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?
Respiratory Exchange Ratio (RER) during cycling exercise (time frame: 0-18 minutes). 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 13 Oct 2017.