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Completed

NCT Number: NCT01534663

Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Columbia University Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age greater than 18 years,
  • left ventricular ejection fraction less than or equal to 35%,
  • stable on standard HF medications, and
  • optimal medical therapy.

Exclusion criteria

  • 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).

Treatment and study plan

Glutamine and Fish Oil Supplementation

Drug

This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.

Placebo

Drug

This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.

Primary outcomes

  1. Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)

    Time frame: 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)).

  2. 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)

    Time frame: 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)).

  3. Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)

    Time frame: 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.

  4. 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)

    Time frame: 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.

  5. Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))

    Time frame: 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.

  6. 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))

    Time frame: 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.

  7. Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)

    Time frame: 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.

  8. 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)

    Time frame: 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.

  9. Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)

    Time frame: 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.

  10. 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)

    Time frame: 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.

  11. Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)

    Time frame: 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.

  12. 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)

    Time frame: 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.

  13. Percent Change in Peak Effort Oxygen Consumption

    Time frame: Baseline to 90 Days

    Peak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET).

Secondary outcomes

  1. Baseline Systemic and Local Inflammation

    Time frame: Baseline

    Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL

  2. 90 Day Systemic and Local Inflammation

    Time frame: 90 Days

    Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Acronym: GLUTFISH-HF

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 17, 2012
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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