ExerciseNCT06846840
Ketone Esters and Metabolism During Recovery from Endurance Exercise
A study testing Ketone ester in people with Exercise and Metabolism, run by University of Bath at 1 site in United Kingdom.
Trial summary
Infusion of beta-hydroxybutyrate can suppress endogenous glucose production, which may result in increased net liver glycogen storage. If ketone esters exert similar effects, then the increase in liver glycogen storage may have implication for recovery from exercise and subsequent exercise performance. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Metabolism
- What is being tested?
- Ketone ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- VO2max ≥ 45mL.kg-1.min-1
- Weekly aerobic training > 3hours.
- 2years running experience.
- BMI < 30kg/m2
Who cannot join
- <18yrs or >60yrs of age
- Habitual smoker within last 5 years.
- History of uncontrollable metabolic or respiratory disease.
- Currently taking medication, following a low carbohydrate or ketogenic diet, or consuming nutritional ketone supplements.
- History of Irritable Bowel Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ketone Esters Ingested During Recovery on Metabolism and Subsequent Exercise Capacity
Infusion of beta-hydroxybutyrate can suppress endogenous glucose production, which may result in increased net liver glycogen storage. If ketone esters exert similar effects, then the increase in liver glycogen storage may have implication for recovery from exercise and subsequent exercise performance.
The aim of this study is to assess the effects of ketone esters ingested during recovery from exercise, on metabolism and subsequent exercise capacity.
- Conditions
- Exercise, Metabolism
- Being tested
- Ketone ester, Placebo
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone esterDietary supplement
0.29 g per kilogram body mass per hour of ketone monoester (R)-3-hydroxybutyrate (R)-3-hydroxybutyl
PlaceboDietary supplement
Medium chain triglycerides and bitter tastant (Bitrex)
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Energy matched placebo containing medium-chain triglycerides and bitter taste Receives: Dietary Supplement: Placebo |
| KETONE | Experimental | Beta-hydroxybutyrate monoester Receives: Dietary Supplement: Ketone ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentrations
Blood glucose concentrations during the recovery period (240 minutes)
Measured: 240 minutes
Secondary outcomes (2)
Non-oxidative fate of ingested sucrose
Non-oxidative fate of ingested glucose measured by appearance of 13C on breath CO2 from high 13C sucrose ingested during recovery
Measured: 240 minutes
Exercise capacity
Time to exhaustion running at 70% of maximal aerobic capacity after the recovery period
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Nov 2024
- Primary completion17 Feb 2025
- Study completion1 May 2025 (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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846840
- Sponsor's protocol ID
- 5202-6834
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan is to share individual deidentied data on a public repository such as Mendeleydata.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketone Esters Ingested During Recovery on Metabolism and Subsequent Exercise Capacity
- ClinicalTrials.gov ID
- NCT06846840
- Acronym / sponsor ID
- 5202-6834
- Conditions
- Exercise, Metabolism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 26 Feb 2025 (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.
Infusion of beta-hydroxybutyrate can suppress endogenous glucose production, which may result in increased net liver glycogen storage. If ketone esters exert similar effects, then the increase in liver glycogen storage may have implication for recovery from exercise and subsequent exercise performance.
The aim of this study is to assess the effects of ketone esters ingested during recovery from exercise, on metabolism and subsequent exercise capacity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Dietary Supplement: PlaceboEnergy matched placebo containing medium-chain triglycerides and bitter taste |
| KETONE | Experimental | Dietary Supplement: Ketone esterBeta-hydroxybutyrate monoester |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- VO2max ≥ 45mL.kg-1.min-1
- Weekly aerobic training > 3hours.
- 2years running experience.
- BMI < 30kg/m2
Key exclusion criteria (5 listed)
- <18yrs or >60yrs of age
- Habitual smoker within last 5 years.
- History of uncontrollable metabolic or respiratory disease.
- Currently taking medication, following a low carbohydrate or ketogenic diet, or consuming nutritional ketone supplements.
- History of Irritable Bowel Syndrome
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 ester0.29 g per kilogram body mass per hour of ketone monoester (R)-3-hydroxybutyrate (R)-3-hydroxybutyl | Dietary supplement | KETONE |
| PlaceboMedium chain triglycerides and bitter tastant (Bitrex) | Dietary supplement | PLACEBO |
Primary outcome
Glucose concentrations
Time frame: 240 minutes
Blood glucose concentrations during the recovery period (240 minutes)
2 secondary outcomes
Non-oxidative fate of ingested sucrose
Time frame: 240 minutes
Exercise capacity
Time frame: 240 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: Yes. Plan is to share individual deidentied data on a public repository such as Mendeleydata.
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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 ester in people with Exercise and Metabolism, run by University of Bath at 1 site in United Kingdom.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Glucose concentrations (time frame: 240 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 26 Feb 2025.