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

NCT06715748 | Recruiting Phase 4

• 1 other identifier: B2432023000008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise-induced Myocardial Damage; Right Ventricular Diastolic Dysfunction

Keywords

Exercise induced cardiac damage; Exogeneous ketone; Cardiac Recovery; CMR; Cardiac US; Troponine; Lpa; Exercise-CMR

Outcome Measures

Primary Outcomes (2)

• Troponin release after identical strenuous exercise is significant different with Ketone ester supplementation compared to Placebo

  All participants will do two identical streneous exercise within two weeks, day 1 with intake of Keton ester and day 2 with intake of Placebo. All participants will recieve baseline, post race and 20-24 hours post baseline investigations.

• Change in contractile reserve measured with Exercise-CMR after identical streneous exercise will be significant different with Ketone ester supplementation compared to placebo.

  All participants will do two identical streneous exercise within two weeks, day 1 with intake of Keton ester and day 2 with intake of Placebo. All participants will recieve baseline, post race and 20-24 hours post baseline investigations.

Secondary Outcomes (3)

• 20-24h after indentical streneous exercise, recuperation of ventricular contractile reserve measured with Exercise-CMR will be significant different with Ketone ester supplementation compared to placebo.

  All participants will do two identical streneous exercise within two weeks, day 1 with intake of Keton ester and day 2 with intake of Placebo. All participants will recieve baseline, post race and 20-24 hours post baseline investigations.

• Change in T1-mapping values measured on CMR after identical strenuous exercise is significant different with Ketone ester supplementation compared to Placebo

  All participants will do two identical streneous exercise within two weeks, day 1 with intake of Keton ester and day 2 with intake of Placebo. All participants will recieve baseline, post race and 20-24 hours post baseline investigations.

• Change in T2-mapping values measured on CMR after identical strenuous exercise is significant different with Ketone ester supplementation compared to Placebo

  All participants will do two identical streneous exercise within two weeks, day 1 with intake of Keton ester and day 2 with intake of Placebo. All participants will recieve baseline, post race and 20-24 hours post baseline investigations.

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Keton

ACTIVE COMPARATOR

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.

Dietary Supplement: Ketone Monoester (KE)

Interventions

Ketone Monoester (KE) DIETARY_SUPPLEMENT

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.

Keton

Placebo DIETARY_SUPPLEMENT

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.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Cardiovascular, metabolic, or respiratory diseases
• Participants with cardiovascular risk factors
• Contraindications for maximum exercise
• Contraindications for MRI.

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

Related Publications (1)

• Ghekiere O, Herbots L, Peters B, Berg BV, Dresselaers T, Franssen W, Padovani B, Ducreux D, Ferrari E, Nchimi A, Demanez S, De Bosscher R, Willems R, Heidbuchel H, La Gerche A, Claessen G, Bogaert J, Eijnde BO. Exercise-induced myocardial T1 increase and right ventricular dysfunction in recreational cyclists: a CMR study. Eur J Appl Physiol. 2023 Oct;123(10):2107-2117. doi: 10.1007/s00421-023-05259-4. Epub 2023 Jul 22.

  PMID: 37480391 BACKGROUND

Central Study Contacts

Benjamin Peters, MD

CONTACT

+32 11 33 55 55; benjamin.peters@jessazh.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 4, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All data will be available 3 months after summary data are published
• Access Criteria: Data will be available upon request from the principal investigator, who will provide a secure clould solution to acces the data.

Locations

BE (1)