Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
- Conditions
- Heart Failure
- Interventions
- Drug: PlaceboDrug: Glutamine and Fish Oil Supplementation
- Registration Number
- NCT01534663
- Lead Sponsor
- Columbia University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- age greater than 18 years,
- left ventricular ejection fraction less than or equal to 35%,
- stable on standard HF medications, and
- optimal medical therapy.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo. Glutamine/Fishoil Glutamine and Fish Oil Supplementation 3.285 g of EPA and 3.285 g of Docosahexaenoic acid (DHA) and L-alanyl-glutamine (8g/d).
- Primary Outcome Measures
Name Time Method Percent Change in Peak Effort Oxygen Consumption 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) 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) 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) 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) 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)) 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)) 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) 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) 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) 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) 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Baseline Systemic and Local Inflammation Baseline Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL
90 Day Systemic and Local Inflammation 90 Days Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL
Trial Locations
- Locations (1)
Columbia University Medical Center
🇺🇸New York, New York, United States