Exercise MetabolismKETONENCT06746805
The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise
A study testing CHO+KETONE in people with Exercise Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to examine the effect of exogenous ketone body supplementation on carbohydrate metabolism during exercise. In a randomized, crossover, and double-blind study, 20 endurance trained adult males and females aged 18-50 years, will ingest carbohydrates with either a ketone monoester supplement… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Metabolism
- What is being tested?
- CHO+KETONE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Mar 2024to 30 Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years of age
- Trained cyclist/triathlete (VO2peak > 55 ml/kg/min for males and >48 ml/mg/min for females)
- Healthy as per medical history and investigator's/physician's judgement
- Having given written informed consent
Who cannot join
- Use of medication that could impact study outcomes and/or interfere with the expected mechanism of action of ketone supplements (e.g. Chronic use of gastric acid suppressing medication, statins, corticosteroids)
- Smoking
- Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes (e.g. Diabetes mellitus)
- Diagnosed musculoskeletal disorders
- Adhering to a carbohydrate restrictive diet
- Participation in another study at the same time
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- Blood donation in the 2 months before the first experimental trial
- Plasma donation in the 2 weeks before the first experimental trial
- Males: VO2peak <55 ml/min/kg body mass
- Females: VO2peak <48 ml/min/kg body mass
- Females: pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
LJC van Loon, Professor, 0031433881397, L.vanLoon@maastrichtuniversity.nl
Philippe Pinckaers, MSc
About this study
Official title: The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise Performed With High Rates of Carbohydrate Ingestion in Trained Cyclists
The purpose of this study is to examine the effect of exogenous ketone body supplementation on carbohydrate metabolism during exercise. In a randomized, crossover, and double-blind study, 20 endurance trained adult males and females aged 18-50 years, will ingest carbohydrates with either a ketone monoester supplement before and throughout a 3-hour exercise session or carbohydrates with a flavour-matched ketone-free placebo. The main aim of this study is to compare the exogenous carbohydrate oxidation rates during exercise between the ketone monoester and placebo conditions.
- Conditions
- Exercise Metabolism
- Being tested
- CHO+KETONE, CHO+PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHO+KETONEDietary supplement
Sports drink containing glucose and ketone mono-esters
CHO+PLACEBODietary supplement
Sports drink containing glucose and placebo
| Study group | Role | What they receive |
|---|---|---|
| CHO+KETONE | Experimental | Interventional drink with glucose + ketone monoester Receives: Dietary Supplement: CHO+KETONE |
| CHO+PLACEBO | Placebo comparator | Placebo drink with glucose + placebo Receives: Dietary Supplement: CHO+PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exogenous carbohydrate oxidation rate
Exogenous carbohydrate oxidation rate during exercise measured by 13C enrichment in breath. CHO+KETONE vs CHO+PLACEBO condition
Measured: Acute:during 3 hours of exercise
Secondary outcomes (7)
Endogenous carbohydrate disappearance rate
Endogenous carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition
Measured: Acute:during 3 hours of exercise
Exogenous carbohydrate disappearance rate
Exogenous carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition
Measured: Acute:during 3 hours of exercise
Total carbohydrate disappearance rate
Total carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition
Measured: Acute:during 3 hours of exercise
Exogenous carbohydrate appearance rate
Exogenous carbohydrate appearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition
Measured: Acute:during 3 hours of exercise
Endogenous carbohydrate appearance rate
Endogenous carbohydrate appearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition
Measured: Acute:during 3 hours of exercise
Total carbohydrate appearance rate
Total carbohydrate appearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition
Measured: Acute:during 3 hours of exercise
Plasma glucose enrichments during exercise
Plasma glucose enrichments during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition
Measured: Acute:during 3 hours of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start4 Mar 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise MetabolismStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomized, placebo-controlled, cross-over trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746805
- Sponsor's protocol ID
- METC 23-001
- Acronym
- KETONE
- Status last verified
- May 2025
- First submitted
- 11 Mar 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon request
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise Performed With High Rates of Carbohydrate Ingestion in Trained Cyclists
- ClinicalTrials.gov ID
- NCT06746805
- Acronym / sponsor ID
- KETONE / METC 23-001
- Conditions
- Exercise Metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Dec 2024 (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 purpose of this study is to examine the effect of exogenous ketone body supplementation on carbohydrate metabolism during exercise. In a randomized, crossover, and double-blind study, 20 endurance trained adult males and females aged 18-50 years, will ingest carbohydrates with either a ketone monoester supplement before and throughout a 3-hour exercise session or carbohydrates with a flavour-matched ketone-free placebo. The main aim of this study is to compare the exogenous carbohydrate oxidation rates during exercise between the ketone monoester and placebo conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| CHO+KETONE | Experimental | Dietary Supplement: CHO+KETONEInterventional drink with glucose + ketone monoester |
| CHO+PLACEBO | Placebo comparator | Dietary Supplement: CHO+PLACEBOPlacebo drink with glucose + placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-50 years of age
- Trained cyclist/triathlete (VO2peak > 55 ml/kg/min for males and >48 ml/mg/min for females)
- Healthy as per medical history and investigator's/physician's judgement
- Having given written informed consent
Key exclusion criteria (11 listed)
- Use of medication that could impact study outcomes and/or interfere with the expected mechanism of action of ketone supplements (e.g. Chronic use of gastric acid suppressing medication, statins, corticosteroids)
- Smoking
- Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes (e.g. Diabetes mellitus)
- Diagnosed musculoskeletal disorders
- Adhering to a carbohydrate restrictive diet
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 |
|---|---|---|
| CHO+KETONESports drink containing glucose and ketone mono-esters | Dietary supplement | CHO+KETONE |
| CHO+PLACEBOSports drink containing glucose and placebo | Dietary supplement | CHO+PLACEBO |
Primary outcome
Exogenous carbohydrate oxidation rate
Time frame: Acute:during 3 hours of exercise
Exogenous carbohydrate oxidation rate during exercise measured by 13C enrichment in breath. CHO+KETONE vs CHO+PLACEBO condition
7 secondary outcomes
Endogenous carbohydrate disappearance rate
Time frame: Acute:during 3 hours of exercise
Exogenous carbohydrate disappearance rate
Time frame: Acute:during 3 hours of exercise
Total carbohydrate disappearance rate
Time frame: Acute:during 3 hours of exercise
Exogenous carbohydrate appearance rate
Time frame: Acute:during 3 hours of exercise
Endogenous carbohydrate appearance rate
Time frame: Acute:during 3 hours of exercise
Total carbohydrate appearance rate
Time frame: Acute:during 3 hours of exercise
Plasma glucose enrichments during exercise
Time frame: Acute:during 3 hours of exercise
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 24 Sep 2025.
- Individual participant dataSharing planned: Undecided. Data will be made available upon request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHO+KETONE in people with Exercise Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
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 11 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: looking for participants now, as of the sponsor's last update on 24 Sep 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 Netherlands. 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?
Contact Luc van Loon, PhD (0031 43 388 1743, l.vanloon@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exogenous carbohydrate oxidation rate (time frame: Acute:during 3 hours of 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 24 Sep 2025.