NCT06715748 Effects of Exogenous Ketones on Acute Changes and Recovery of the Heart Muscle After Intense Exercise.
| NCT ID | NCT06715748 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Jessa Hospital |
| Condition | Exercise-induced Myocardial Damage |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-10-17 |
| Primary Completion | 2026-12-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2024-10-17 with a primary completion date of 2026-12-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It is well known that scar tissue on the heart muscle can cause (life-threatening) arrhythmias. However, the exact cause of this scar tissue is not entirely clear. It is possible that prolonged and intense exercise is associated with (limited) inflammation of the heart muscle, carrying the risk of scar tissue development. The aim of this project is to evaluate the impact of prolonged and intense exercise on the heart. Participants will be asked to cycle for a total of 3 hours, of which 2 hours will be at an intense pace. Approximately 30 recreational cyclists will be invited to participate in this research project. Specifically, the investigators want to examine whether prolonged and intense exercise is associated with inflammation of the heart muscle and whether it affects heart function recovery. The research project will take place in a laboratory setting, where heart rate, blood pressure, food and fluid intake, and exertion level will be monitored. Before, after and 20-24h after the intense exercise, a lab test and extensive heart imaging will be performed using magnetic resonance imaging (MRI) and cardiac ultrasound. The investigators aim to study the effect of ketone intake (a dietary supplement that may enhance performance or recovery) on recovery. For this, a double blind cross-over design will be setup. Participants will complete the same exercise twice, with a 1-3 week interval, once with a placebo and once with ketones. All the same baseline, post-exercise and recovery investigations will be perfromed. In the second part of the study, the investigators will evaluate and compare various rhythm-monitoring devices, both during intense exercise and in daily life. For this, participants will be asked to wear each of four devices for one week in a home setting. These are very small devices that are not externally visible when worn under clothing. Participation in this project will involve a various questionnaires and tests.
Eligibility Criteria
Inclusion Criteria: * healthy recreational male and female cyclists between 18 and 50 years old, who have signed an informed consent form. * Participants will be included if they achieve a VO2-max/kg value above P90, corrected for age and sex, based on the reference value by E. Van der Steeg et al. Exclusion Criteria: * Cardiovascular, metabolic, or respiratory diseases * Participants with cardiovascular risk factors * Contraindications for maximum exercise * Contraindications for MRI.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06715748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Exercise-induced Myocardial Damage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06715748 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06715748 currently recruiting?
Yes, NCT06715748 is actively recruiting participants. Contact the research team at benjamin.peters@jessazh.be for enrollment information.
Where is the NCT06715748 trial being conducted?
This trial is being conducted at Hasselt, Belgium.
Who is sponsoring the NCT06715748 clinical trial?
NCT06715748 is sponsored by Jessa Hospital. The trial plans to enroll 30 participants.