Trial · NCT01534663
Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
NCT01534663, Phase 2, Phase 3, Completed, Columbia University; results first posted 2020-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure. Trials, record NCT01534663. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01534663
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
- NCT number
- NCT01534663
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Heart Failure
- Interventions
- Glutamine and Fish Oil Supplementation, Placebo
- First posted
- 2012-02-17
- Last updated
- 2020-12-22
- Results first posted
- 2020-12-22
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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)). |
| Primary | 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)). |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Baseline | Percent | MEAN | |
| PRIMARY | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | 90 Days | Percent | MEAN | |
| PRIMARY | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Baseline | Percent | MEAN | |
| PRIMARY | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | 90 Days | Percent | MEAN | |
| PRIMARY | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Baseline | Percent | MEAN | |
| PRIMARY | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | 90 Days | Percent | MEAN | |
| PRIMARY | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Baseline | Joules | MEAN | |
| PRIMARY | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | 90 Days | Joules | MEAN | |
| PRIMARY | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Baseline | Watts | MEAN | |
| PRIMARY | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | 90 Days | Watts | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group182
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Placebo | Knee: Extension | 177 | Standard Deviation 18 | Percent |
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Glutamine/Fishoil | Knee: Extension | 196 | Standard Deviation 10 | Percent |
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Placebo | Knee: Flexion | 76 | Standard Deviation 6 | Percent |
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Glutamine/Fishoil | Knee: Flexion | 90 | Standard Deviation 5 | Percent |
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Placebo | Elbow: Extension | 65 | Standard Deviation 6 | Percent |
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Glutamine/Fishoil | Elbow: Extension | 59 | Standard Deviation 4 | Percent |
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Placebo | Elbow: Flexion | 74 | Standard Deviation 7 | Percent |
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Glutamine/Fishoil | Elbow: Flexion | 71 | Standard Deviation 4 | Percent |
| 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Placebo | Knee: Extension | 200 | Standard Deviation 20 | Percent |
| 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Glutamine/Fishoil | Knee: Extension | 206 | Standard Deviation 11 | Percent |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | STARTED | Glutamine/Fishoil | 17 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | COMPLETED | Glutamine/Fishoil | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Glutamine/Fishoil | 3 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Placebo | 2 | 12 | |
| other | Diarrhea | Gastrointestinal disorders | Glutamine/Fishoil | 1 | 14 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, all-cause mortality | Glutamine/Fishoil | 0 | 14 |
| Total, other adverse events | Placebo | 2 | 12 |
| Total, other adverse events | Glutamine/Fishoil | 1 | 14 |
| Total, serious adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Glutamine/Fishoil | 0 | 14 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Glutamine/Fishoil vs Placebo: deaths from any cause | Trial comparisons |
| Glutamine/Fishoil vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01534663
GET https://conductscience.org/api/trials/v1/NCT01534663/results?page=2