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Effects of Exogenous Ketones on Acute Changes and Recovery of the Heart Muscle After Intense Exercise.

NCT06715748 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Exercise-induced Myocardial Damage
  • Right Ventricular Diastolic Dysfunction

Interventions

DIETARY_SUPPLEMENT

Ketone Monoester (KE)

Participants will perform a randomized, double-blind ZWIFT event, once with ketone ester intake and once with placebo, separated by an interval of 1-4 weeks. Ketones and placebo will be orally administered according to a fixed schedule.

DIETARY_SUPPLEMENT

Placebo

Participants will perform a randomized, double-blind ZWIFT event, once with ketone ester intake and once with placebo, separated by an interval of 1-3 weeks. Ketones and placebo will be orally administered according to a fixed schedule.

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-17
Primary Completion
2026-12-22
Completion
2026-12-22

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715748 on ClinicalTrials.gov