Prospective Study Investigating the Effects of Intense Endurance Exercise on the Heart Muscle and the Effect of Exogenous Ketones on Acute Changes and Recovery of the Heart Muscle.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Troponin release after identical strenuous exercise is significant different with Ketone ester supplementation compared to Placebo
研究概览
简要总结
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.
详细描述
BACKGROUND:
It has already been established that extensive exercise results in functional and biochemical myocardial damage. However, the development of exercise-induced myocardial edema remains unclear. Native T1 and T2 mapping techniques in cardiac magnetic resonance imaging (CMR) are sensitive to detecting pathological myocardial fluid accumulation and thus serve as potential biomarkers for identifying pathological myocardial edema. A pilot study conducted by Ghekiere et al. demonstrated a correlation between elevated troponin release and increased T1 mapping values, as well as right ventricular (RV) dysfunction. The objective of this study is to perform an additional study with 30 participants, using an adapted study protocol to overcome the main limitations of the pilot study and to evaluate the effects of exogeneous ketones on acute cardiac changes and recovery.
- OBJECTIVES
This research aims to investigate whether cardiac abnormalities develop following intense exercise and whether these abnormalities recover or persist after 20-24 hours. Specifically, the investigators will examine whether myocardial edema, cardiac dysfunction, or abnormalities in contractile reserve occur after intense exercise. The investigators intend to examine whether the use of ketones influences the occurrence and recovery of these cardiac abnormalities. A pilot study by Ghekiere et al. showed a correlation between exercise-induced troponin release and elevated T1 mapping values, along with RV dysfunction. The goal of this study is to further explore these findings in a larger population. The investigators will evaluate whether extensive exercise is associated with pathological levels of fluid accumulation in the myocardium, potentially indicating pathological myocardial edema. Additionally, the investigators will assess if ventricular dysfunction occurs and whether contractile reserve changes following intense exercise. Finally, the investigators will examine whether previous findings recover or remain 24 hours after intense exercise, as well as any potential differences between men and women, and the influence of intake of ketones. These findings could contribute to research on pathological heart damage and sudden death in professional cyclists and potentially shed light on the effects of ketones on recovery from cardiac injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Cardiovascular, metabolic, or respiratory diseases
- •Participants with cardiovascular risk factors
- •Contraindications for maximum exercise
- •Contraindications for MRI.
结局指标
主要结局
Troponin release after identical strenuous exercise is significant different with Ketone ester supplementation compared to Placebo
时间窗: 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.
时间窗: 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.
次要结局
- 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.)