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Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure (GLUTFISH-HF)

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ClinicalTrials.gov Identifier: NCT01534663
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Christian Schulze, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Glutamine and Fish Oil Supplementation Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Glutamine and Fish Oil on Muscle Function in Heart Failure (GlutFish-HF)
Study Start Date : November 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Placebo Comparator: Placebo
The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.
Drug: Placebo
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.

Active Comparator: Glutamine/Fishoil
3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d).
Drug: Glutamine and Fish Oil Supplementation
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 Outcome Measures :
  1. Skeletal Muscle Function [ Time Frame: 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.


Secondary Outcome Measures :
  1. Systemic and Local Inflammation [ Time Frame: 90 days ]
    A secondary outcome is the measurement of systemic and local markers of inflammation.



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534663


Locations
United States, New York
Columbia University Medical Center
New York City, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Paul Christian Schulze, MD, PhD Columbia University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Schulze, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01534663     History of Changes
Other Study ID Numbers: AAAE8356
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by Christian Schulze, Columbia University:
Heart Failure
Skeletal Muscle Function
Metabolism
Inflammation
Glutamine
Fish oil
Muscle Function

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases