Effects of Glutamine and Fish Oil on Muscle Function in Heart Failure (GlutFish-HF) (GLUTFISH-HF)

NCT01534663 Phase 2/Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Columbia University
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	31
Start date	2011-11
Completion	2014-07

Conditions

• Heart Failure

Interventions

• Glutamine and Fish Oil Supplementation
• Placebo

Primary outcomes

• 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.

Countries

United States