Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise
研究概览
简要总结
In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
详细描述
The goal of this study is to investigate if oral ketone supplementation stimulates mitochondrial ATP production and improves exercise performance in patients with chronic HF. In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment. Endpoints include rate and magnitude of change in phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise, rate and magnitude of change in PCr and Pi concentrations during recovery, rates and magnitude of change in intramuscular pH during exercise and recovery, maximal exercise performance and change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Heart Failure NYHA II - III
- •LVEF ≤40%
- •Stable for the last 1 month prior to the study
排除标准
- •Age <18 years;
- •Unable or unwilling to undergo exercise MRI (physical disabilities, claustrophobia);
- •Unable to complete the exercise protocol during the screening visit according to the professional opinion of the investigators;
- •Comorbidities which can influence study results such as muscular dystrophies, peripheral artery disease, diabetes mellitus, severe anaemia (defined as Hb ≤6 mmol/L);
- •Pregnant/trying to get pregnant/breastfeeding during the period from the first exercise test until 4 weeks after the last exercise test);
- •Absolute contra-indications to undergo MRI according to the current UMCG protocols and guidelines (e.g. non-conditional medical device, recent device implantation, incompatible ferromagnetic objects in the body).
- •BMI < 16 kg/m2; BMI > 35 kg/m2
- •Unable to understand study procedures;
- •Unable or unwilling to provide informed consent.
结局指标
主要结局
Phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise
时间窗: During study-visit
Rate and magnitude of change in PCr and Pi concentrations from baseline to maximum exercise.
次要结局
- Intramuscular pH(During study visit)
- Maximal exercise performance(During study visit)
- Change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise(During study visit)
- Rate and magnitude of change in PCr and Pi concentrations during recovery(During study visit)