Phase 3
Completed N=31
Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
Source: ClinicalTrials.gov NCT01534663 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) — 177; 196; 76; 90 Percent
◆ Published Evidence
Established
38citations · ~3 / year
Supplementation of l-Alanyl-l-Glutamine and Fish Oil Improves Body Composition and Quality of Life in Patients With Chronic Heart Failure.
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.
Linked Publications
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Supplementation of l-Alanyl-l-Glutamine and Fish Oil Improves Body Composition and Quality of Life in Patients With Chronic Heart Failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) |
177; 196; 76; 90; 65; 59 | — |
| PRIMARY 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) |
200; 206; 90; 90; 64; 61 | — |
| PRIMARY Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) |
147; 153; 61; 70; 46; 42 | — |
| PRIMARY 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) |
173; 160; 76; 77; 48; 46 | — |
| PRIMARY Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) |
132; 137; 61; 70; 51; 47 | — |
| PRIMARY 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) |
157; 149; 78; 80; 54; 54 | — |
| PRIMARY Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) |
477; 537; 209; 264; 189; 184 | — |
| PRIMARY 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) |
586; 603; 277; 319; 209; 193 | — |
| PRIMARY Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) |
65; 75; 26; 33; 24; 23 | — |
| PRIMARY 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) |
80; 84; 37; 41; 26; 25 | — |
| PRIMARY Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) |
526; 494; 828; 945; 426; 344 | — |
| PRIMARY 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) |
404; 456; 729; 780; 429; 469 | — |
| PRIMARY Percent Change in Peak Effort Oxygen Consumption |
7.9; 0.1 | — |
| SECONDARY Baseline Systemic and Local Inflammation |
3.4; 3.1 | — |
| SECONDARY 90 Day Systemic and Local Inflammation |
2.5; 3.3 | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01534663) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.