Effects of Glutamine and Fish Oil on Muscle Function in Heart Failure (GlutFish-HF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Percent Change in Peak Effort Oxygen Consumption
研究概览
简要总结
The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation of fish oil and glutamine with placebo in patients with stable heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this study is the change in muscle functional capacity measured as changes in maximum muscle strength and fatigability, peak VO2 and exercise time after supplementation. A secondary outcome is the measurement of systemic and local markers of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than 18 years,
- •left ventricular ejection fraction less than or equal to 35%,
- •stable on standard HF medications, and
- •optimal medical therapy.
排除标准
- •major cardiovascular events,
- •procedures in the last 6 months,
- •dementia,
- •presence of cardiovascular diseases that may lead to harm if the patient took part in the study (congenital heart disease, long QT syndrome, hypertrophic cardiomyopathy, active myocarditis).
研究组 & 干预措施
Placebo
The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.
干预措施: Placebo (Drug)
Glutamine/Fishoil
3.285 g of EPA and 3.285 g of Docosahexaenoic acid (DHA) and L-alanyl-glutamine (8g/d).
干预措施: Glutamine and Fish Oil Supplementation (Drug)
结局指标
主要结局
Percent Change in Peak Effort Oxygen Consumption
时间窗: Baseline to 90 Days
Peak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET).
Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
时间窗: Baseline
For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)).
90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
时间窗: 90 Days
For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)).
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
时间窗: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
时间窗: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
时间窗: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
时间窗: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
时间窗: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
时间窗: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
时间窗: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
时间窗: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
时间窗: Baseline
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
时间窗: 90 Days
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second.
次要结局
- Baseline Systemic and Local Inflammation(Baseline)
- 90 Day Systemic and Local Inflammation(90 Days)
研究者
Paolo Colombo
Professor of Medicine
Columbia University