ExercisePhase 2NCT05407753
Effect of Exogenous Ketosis During Ultra-endurance Exercise
A Phase 2 study testing Ketone ester in people with Exercise and Ultra-endurance Running, run by KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to investigate the effect of oral ketone administration during and immediately after an ultramarathon. Potential changes in cognitive function (reaction time, number of errors), running performance, jump height, skeletal muscle inflammatory infiltration and hormonal alterations will be the… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise, Ultra-endurance Running, Ketosis
- What is being tested?
- Ketone ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 20 May 2021to 31 Dec 2022
- Phase
- Phase 2
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males between 18 and 55 years old
- Recreational or competitive runner having performed an ultramarathon (>42km) during the last 2 years
- Good health status confirmed by a medical screening
- Body Mass Index (BMI) between 18 and 25
Who cannot join
- Any kind of injury/pathology that is a contra-indication to perform ultra-endurance exercise
- Intake of any medication or nutritional supplement that is known to affect exercise performance
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- Blood donation within 3 months prior to the start of the study
- Smoking
- More than 3 alcoholic beverages per day
Show all 9Show fewer
- Current participation in another research trial
- Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
- Adherence to a high-fat, low-carbohydrate ketogenic diet (less than 20% of energy intake derived from carbohydrates)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Ketone Administration on Cognitive Function, Musculoskeletal Damage and Hormonal and Metabolic Dysregulations Induced by Ultra-endurance Running
The aim of this study is to investigate the effect of oral ketone administration during and immediately after an ultramarathon. Potential changes in cognitive function (reaction time, number of errors), running performance, jump height, skeletal muscle inflammatory infiltration and hormonal alterations will be the main focus. In this context, subjects (n=24) will perform a 100km ultrarunning trail, while receiving either ketone ester (KE, n =12) or placebo (CON, n=12). Experimental measurements will be performed immediately before and after the ultramarathon as well as 24h after the ultramarathon.
- Conditions
- Exercise, Ultra-endurance Running, Ketosis, Skeletal Muscle, Cognitive Function
- Being tested
- Ketone ester, 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 esterDietary supplement
Subjects receive the ketone ester at the following timepoints: 25g before ultrarun, 12.5g every 30 min during race, 25g immediately after race, 25g before sleep, 3 x 25g on day after race.
PlaceboDietary supplement
Subjects receive a non-caloric taste-matched placebo (water with sucrose octaacetate)
| Study group | Role | What they receive |
|---|---|---|
| Ketone ester | Experimental | Subjects receive the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (25g before ultrarun, 12.5g every 30 min during race, 25g immediately after race, 25g before sleep, 3 x 25g on day after race. Receives: Dietary Supplement: Ketone ester |
| Con | Placebo comparator | Subjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time
Change in reaction time during a reaction time task
Measured: Before race - immediately after race
Countermovent jump
Change in countermovement jump height
Measured: Before race - immediately after race - 48 hours after start of race
Exercise performance
Time needed to complete the ultrarun
Measured: Immediately after race
Skeletal muscle inflammatory cell infiltration
Change in infiltration of inflammatory cells in skeletal muscle
Measured: Before race - 48 hours after start of race
Secondary outcomes (1)
Catecholamines in blood
Change in catecholamine concentration in plasma
Measured: Before race - immediately after race - 48 hours after start of race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start20 May 2021
- Primary completion24 Oct 2021
- Study completion31 Dec 2022 (estimated)
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 KU LeuvenThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hespel, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407753
- Sponsor's protocol ID
- S65311
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 7 Jun 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 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Ketone Administration on Cognitive Function, Musculoskeletal Damage and Hormonal and Metabolic Dysregulations Induced by Ultra-endurance Running
- ClinicalTrials.gov ID
- NCT05407753
- Acronym / sponsor ID
- S65311
- Conditions
- Exercise, Ultra-endurance Running, Ketosis, Skeletal Muscle, Cognitive Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 24 Oct 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jun 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.
The aim of this study is to investigate the effect of oral ketone administration during and immediately after an ultramarathon. Potential changes in cognitive function (reaction time, number of errors), running performance, jump height, skeletal muscle inflammatory infiltration and hormonal alterations will be the main focus. In this context, subjects (n=24) will perform a 100km ultrarunning trail, while receiving either ketone ester (KE, n =12) or placebo (CON, n=12). Experimental measurements will be performed immediately before and after the ultramarathon as well as 24h after the ultramarathon.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone ester | Experimental | Dietary Supplement: Ketone esterSubjects receive the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (25g before ultrarun, 12.5g every 30 min during race, 25g immediately after race, 25g before sleep, 3 x 25g on day after race. |
| Con | Placebo comparator | Dietary Supplement: PlaceboSubjects receive a non-caloric, taste matched placebo (water and sucrose octaacetate). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males between 18 and 55 years old
- Recreational or competitive runner having performed an ultramarathon (>42km) during the last 2 years
- Good health status confirmed by a medical screening
- Body Mass Index (BMI) between 18 and 25
Key exclusion criteria (9 listed)
- Any kind of injury/pathology that is a contra-indication to perform ultra-endurance exercise
- Intake of any medication or nutritional supplement that is known to affect exercise performance
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- Blood donation within 3 months prior to the start of the study
- Smoking
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 esterSubjects receive the ketone ester at the following timepoints: 25g before ultrarun, 12.5g every 30 min during race, 25g immediately after race, 25g before sleep, 3 x 25g on day after race. | Dietary supplement | Ketone ester |
| PlaceboSubjects receive a non-caloric taste-matched placebo (water with sucrose octaacetate) | Dietary supplement | Con |
Primary outcome
Reaction time
Time frame: Before race - immediately after race
Change in reaction time during a reaction time task
Countermovent jump
Time frame: Before race - immediately after race - 48 hours after start of race
Change in countermovement jump height
Exercise performance
Time frame: Immediately after race
Time needed to complete the ultrarun
Skeletal muscle inflammatory cell infiltration
Time frame: Before race - 48 hours after start of race
Change in infiltration of inflammatory cells in skeletal muscle
1 secondary outcome
Catecholamines in blood
Time frame: Before race - immediately after race - 48 hours after start of race
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 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.
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 Phase 2 study testing Ketone ester in people with Exercise and Ultra-endurance Running, run by KU Leuven at 1 site in Belgium.
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 9 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: status not confirmed, as of the sponsor's last update on 7 Jun 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Reaction time (time frame: Before race - immediately after race). The study lists 4 primary outcomes in all. 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 Jun 2022.