The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise (NCT06746805) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise
Netherlands27 participantsStarted 2024-03-04
Plain-language 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 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.