Heart Failure
Conditions
Keywords
Heart Failure, Skeletal Muscle Function, Metabolism, Inflammation, Glutamine, Fish oil, Muscle Function
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.
Interventions
DRUGGlutamine 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.
DRUGPlacebo
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.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Peak Effort Oxygen Consumption | Baseline to 90 Days | Peak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET). |
| Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | 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 (Time to Peak Torque) | 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90 Day Systemic and Local Inflammation | 90 Days | Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL |
| Baseline Systemic and Local Inflammation | Baseline | Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL |
Countries
United States
Participant flow
Pre-assignment details
Seventeen participants were randomized to the active treatment group and 14 to the placebo group. Three participants dropped out in the active treatment group. Two participants dropped out of the placebo group. A total of 14 participants completed the trial in the active treatment group and 12 in the placebo group.
Participants by arm
| Arm | Count |
|---|---|
| Placebo The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.
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. | 12 |
| Glutamine/Fishoil 3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d).
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. | 14 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | Glutamine/Fishoil | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 2 | 59 years STANDARD_DEVIATION 3 | 59 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 12 participants | 14 participants | 26 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 2 / 12 | 1 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
Primary
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
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.
Time frame: 90 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Extension, 5 repetitions | 26 Watts | Standard Deviation 3 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Extension, 25 repetitions | 128 Watts | Standard Deviation 13 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Flexion, 25 repetitions | 50 Watts | Standard Deviation 7 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Flexion, 5 repetitions | 37 Watts | Standard Deviation 6 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Extension, 25 repetitions | 40 Watts | Standard Deviation 6 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Flexion, 5 repetitions | 34 Watts | Standard Deviation 4 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Flexion, 25 repetitions | 62 Watts | Standard Deviation 8 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Extension, 5 repetitions | 80 Watts | Standard Deviation 9 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Flexion, 25 repetitions | 57 Watts | Standard Deviation 4 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Extension, 5 repetitions | 84 Watts | Standard Deviation 7 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Extension, 25 repetitions | 140 Watts | Standard Deviation 15 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Flexion, 5 repetitions | 41 Watts | Standard Deviation 5 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Extension, 5 repetitions | 25 Watts | Standard Deviation 2 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Flexion, 5 repetitions | 34 Watts | Standard Deviation 2 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Flexion, 25 repetitions | 56 Watts | Standard Deviation 7 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Extension, 25 repetitions | 36 Watts | Standard Deviation 4 |
Primary
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
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.
Time frame: 90 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Extension, 5 repetitions | 173 Percent | Standard Deviation 20 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Flexion, 25 repetitions | 58 Percent | Standard Deviation 4 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Flexion, 5 repetitions | 76 Percent | Standard Deviation 9 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Extension, 5 repetitions | 48 Percent | Standard Deviation 5 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Flexion, 5 repetitions | 56 Percent | Standard Deviation 4 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Extension, 25 repetitions | 115 Percent | Standard Deviation 10 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Extension, 25 repetitions | 38 Percent | Standard Deviation 4 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Flexion, 25 repetitions | 55 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Flexion, 25 repetitions | 51 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Extension, 5 repetitions | 160 Percent | Standard Deviation 9 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Flexion, 5 repetitions | 57 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Flexion, 25 repetitions | 67 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Extension, 25 repetitions | 36 Percent | Standard Deviation 2 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Flexion, 5 repetitions | 77 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Extension, 25 repetitions | 108 Percent | Standard Deviation 6 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Extension, 5 repetitions | 46 Percent | Standard Deviation 2 |
Primary
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
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.
Time frame: 90 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Extension, 5 repetitions | 429 msec | Standard Deviation 65 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Extension, 25 repetitions | 186 msec | Standard Deviation 12 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Flexion, 25 repetitions | 366 msec | Standard Deviation 53 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Flexion, 5 repetitions | 808 msec | Standard Deviation 77 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Extension, 25 repetitions | 417 msec | Standard Deviation 54 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Extension, 5 repetitions | 404 msec | Standard Deviation 37 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Flexion, 25 repetitions | 420 msec | Standard Deviation 48 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Flexion, 5 repetitions | 729 msec | Standard Deviation 45 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Flexion, 25 repetitions | 426 msec | Standard Deviation 43 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Extension, 5 repetitions | 469 msec | Standard Deviation 45 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Flexion, 5 repetitions | 996 msec | Standard Deviation 80 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Extension, 25 repetitions | 177 msec | Standard Deviation 12 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Flexion, 5 repetitions | 780 msec | Standard Deviation 93 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Flexion, 25 repetitions | 507 msec | Standard Deviation 32 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Extension, 25 repetitions | 314 msec | Standard Deviation 47 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Extension, 5 repetitions | 456 msec | Standard Deviation 27 |
Primary
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
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.
Time frame: 90 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Extension, 5 repetitions | 586 Joules | Standard Deviation 69 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Flexion, 5 repetitions | 277 Joules | Standard Deviation 44 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Extension, 5 repetitions | 209 Joules | Standard Deviation 26 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Flexion, 5 repetitions | 272 Joules | Standard Deviation 27 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Extension, 25 repetitions | 1806 Joules | Standard Deviation 176 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Flexion, 25 repetitions | 765 Joules | Standard Deviation 99 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Extension, 25 repetitions | 655 Joules | Standard Deviation 83 |
| Placebo | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Flexion, 25 repetitions | 1079 Joules | Standard Deviation 118 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Flexion, 25 repetitions | 987 Joules | Standard Deviation 55 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Extension, 5 repetitions | 603 Joules | Standard Deviation 51 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Extension, 25 repetitions | 1816 Joules | Standard Deviation 168 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Flexion, 5 repetitions | 319 Joules | Standard Deviation 33 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Extension, 25 repetitions | 598 Joules | Standard Deviation 50 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Extension, 5 repetitions | 193 Joules | Standard Deviation 18 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Flexion, 25 repetitions | 813 Joules | Standard Deviation 99 |
| Glutamine/Fishoil | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Flexion, 5 repetitions | 283 Joules | Standard Deviation 15 |
Primary
90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
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)).
Time frame: 90 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Knee: Extension | 200 Percent | Standard Deviation 20 |
| Placebo | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Knee: Flexion | 90 Percent | Standard Deviation 8 |
| Placebo | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Elbow: Extension | 64 Percent | Standard Deviation 6 |
| Placebo | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Elbow: Flexion | 74 Percent | Standard Deviation 6 |
| Glutamine/Fishoil | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Elbow: Flexion | 74 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Knee: Extension | 206 Percent | Standard Deviation 11 |
| Glutamine/Fishoil | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Elbow: Extension | 61 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Knee: Flexion | 90 Percent | Standard Deviation 5 |
Primary
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
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.
Time frame: 90 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Extension, 25 repetitions | 111 Percent | Standard Deviation 11 |
| Placebo | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Extension, 5 repetitions | 54 Percent | Standard Deviation 6 |
| Placebo | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Flexion, 25 repetitions | 51 Percent | Standard Deviation 6 |
| Placebo | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Flexion, 5 repetitions | 78 Percent | Standard Deviation 12 |
| Placebo | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Extension, 25 repetitions | 41 Percent | Standard Deviation 4 |
| Placebo | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Flexion, 5 repetitions | 68 Percent | Standard Deviation 5 |
| Placebo | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Flexion, 25 repetitions | 60 Percent | Standard Deviation 5 |
| Placebo | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Extension, 5 repetitions | 157 Percent | Standard Deviation 17 |
| Glutamine/Fishoil | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Flexion, 25 repetitions | 58 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Extension, 5 repetitions | 54 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Extension, 5 repetitions | 149 Percent | Standard Deviation 9 |
| Glutamine/Fishoil | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Flexion, 5 repetitions | 71 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Extension, 25 repetitions | 108 Percent | Standard Deviation 7 |
| Glutamine/Fishoil | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Flexion, 25 repetitions | 55 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Extension, 25 repetitions | 39 Percent | Standard Deviation 2 |
| Glutamine/Fishoil | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Flexion, 5 repetitions | 80 Percent | Standard Deviation 5 |
Primary
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Extension, 5 repetitions | 65 Watts | Standard Deviation 10 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Extension, 25 repetitions | 106 Watts | Standard Deviation 14 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Extension, 5 repetitions | 24 Watts | Standard Deviation 3 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Flexion, 5 repetitions | 26 Watts | Standard Deviation 5 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Extension, 25 repetitions | 37 Watts | Standard Deviation 5 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Flexion, 5 repetitions | 35 Watts | Standard Deviation 4 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Flexion, 25 repetitions | 64 Watts | Standard Deviation 9 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Flexion, 25 repetitions | 26 Watts | Standard Deviation 7 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Flexion, 25 repetitions | 57 Watts | Standard Deviation 5 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Extension, 5 repetitions | 75 Watts | Standard Deviation 33 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Flexion, 5 repetitions | 33 Watts | Standard Deviation 5 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Extension, 5 repetitions | 23 Watts | Standard Deviation 3 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Flexion, 5 repetitions | 32 Watts | Standard Deviation 3 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Extension, 25 repetitions | 121 Watts | Standard Deviation 13 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Knee: Flexion, 25 repetitions | 46 Watts | Standard Deviation 7 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | Elbow: Extension, 25 repetitions | 38 Watts | Standard Deviation 5 |
Primary
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Extension, 5 repetitions | 147 Percent | Standard Deviation 17 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Extension, 25 repetitions | 103 Percent | Standard Deviation 10 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Extension, 5 repetitions | 46 Percent | Standard Deviation 5 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Flexion, 25 repetitions | 55 Percent | Standard Deviation 5 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Flexion, 5 repetitions | 61 Percent | Standard Deviation 6 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Extension, 25 repetitions | 37 Percent | Standard Deviation 3 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Flexion, 5 repetitions | 61 Percent | Standard Deviation 6 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Flexion, 25 repetitions | 56 Percent | Standard Deviation 5 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Flexion, 5 repetitions | 54 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Extension, 5 repetitions | 153 Percent | Standard Deviation 8 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Flexion, 5 repetitions | 70 Percent | Standard Deviation 5 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Extension, 5 repetitions | 42 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Flexion, 25 repetitions | 50 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Extension, 25 repetitions | 105 Percent | Standard Deviation 7 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Knee: Flexion, 25 repetitions | 96 Percent | Standard Deviation 33 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | Elbow: Extension, 25 repetitions | 35 Percent | Standard Deviation 2 |
Primary
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Extension, 25 repetitions | 376 msec | Standard Deviation 58 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Extension, 5 repetitions | 526 msec | Standard Deviation 44 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Flexion, 5 repetitions | 828 msec | Standard Deviation 104 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Extension, 5 repetitions | 426 msec | Standard Deviation 50 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Flexion, 5 repetitions | 806 msec | Standard Deviation 89 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Extension, 25 repetitions | 195 msec | Standard Deviation 12 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Flexion, 25 repetitions | 399 msec | Standard Deviation 61 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Flexion, 25 repetitions | 435 msec | Standard Deviation 52 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Flexion, 25 repetitions | 426 msec | Standard Deviation 42 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Extension, 25 repetitions | 417 msec | Standard Deviation 50 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Flexion, 5 repetitions | 1003 msec | Standard Deviation 76 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Extension, 5 repetitions | 494 msec | Standard Deviation 27 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Flexion, 25 repetitions | 546 msec | Standard Deviation 11 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Flexion, 5 repetitions | 945 msec | Standard Deviation 84 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Knee: Extension, 25 repetitions | 212 msec | Standard Deviation 27 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | Elbow: Extension, 5 repetitions | 344 msec | Standard Deviation 26 |
Primary
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Extension, 5 repetitions | 477 Joules | Standard Deviation 64 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Flexion, 5 repetitions | 209 Joules | Standard Deviation 35 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Extension, 5 repetitions | 189 Joules | Standard Deviation 23 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Flexion, 5 repetitions | 280 Joules | Standard Deviation 35 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Extension, 25 repetitions | 1551 Joules | Standard Deviation 200 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Flexion, 25 repetitions | 552 Joules | Standard Deviation 102 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Extension, 25 repetitions | 590 Joules | Standard Deviation 72 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Flexion, 25 repetitions | 1108 Joules | Standard Deviation 141 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Flexion, 25 repetitions | 992 Joules | Standard Deviation 74 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Extension, 5 repetitions | 537 Joules | Standard Deviation 50 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Extension, 25 repetitions | 1776 Joules | Standard Deviation 185 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Flexion, 5 repetitions | 264 Joules | Standard Deviation 36 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Extension, 25 repetitions | 612 Joules | Standard Deviation 65 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Extension, 5 repetitions | 184 Joules | Standard Deviation 19 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Knee: Flexion, 25 repetitions | 742 Joules | Standard Deviation 118 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | Elbow: Flexion, 5 repetitions | 261 Joules | Standard Deviation 22 |
Primary
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Extension, 5 repetitions | 51 Percent | Standard Deviation 6 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Extension, 25 repetitions | 100 Percent | Standard Deviation 11 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Flexion, 25 repetitions | 41 Percent | Standard Deviation 6 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Flexion, 5 repetitions | 61 Percent | Standard Deviation 9 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Extension, 25 repetitions | 38 Percent | Standard Deviation 4 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Flexion, 5 repetitions | 70 Percent | Standard Deviation 7 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Flexion, 25 repetitions | 63 Percent | Standard Deviation 6 |
| Placebo | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Extension, 5 repetitions | 132 Percent | Standard Deviation 15 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Flexion, 25 repetitions | 55 Percent | Standard Deviation 3 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Extension, 5 repetitions | 137 Percent | Standard Deviation 8 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Extension, 25 repetitions | 102 Percent | Standard Deviation 7 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Flexion, 5 repetitions | 70 Percent | Standard Deviation 6 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Extension, 5 repetitions | 47 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Flexion, 5 repetitions | 65 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Knee: Flexion, 25 repetitions | 46 Percent | Standard Deviation 6 |
| Glutamine/Fishoil | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | Elbow: Extension, 25 repetitions | 36 Percent | Standard Deviation 3 |
Primary
Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
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)).
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Knee: Extension | 177 Percent | Standard Deviation 18 |
| Placebo | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Knee: Flexion | 76 Percent | Standard Deviation 6 |
| Placebo | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Elbow: Extension | 65 Percent | Standard Deviation 6 |
| Placebo | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Elbow: Flexion | 74 Percent | Standard Deviation 7 |
| Glutamine/Fishoil | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Elbow: Flexion | 71 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Knee: Extension | 196 Percent | Standard Deviation 10 |
| Glutamine/Fishoil | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Elbow: Extension | 59 Percent | Standard Deviation 4 |
| Glutamine/Fishoil | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | Knee: Flexion | 90 Percent | Standard Deviation 5 |
Primary
Percent Change in Peak Effort Oxygen Consumption
Peak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET).
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Peak Effort Oxygen Consumption | 7.9 Percent | Standard Deviation 4.7 |
| Glutamine/Fishoil | Percent Change in Peak Effort Oxygen Consumption | 0.1 Percent | Standard Deviation 0.7 |
Secondary
90 Day Systemic and Local Inflammation
Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL
Time frame: 90 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 90 Day Systemic and Local Inflammation | 2.5 pg/mL | Standard Deviation 0.4 |
| Glutamine/Fishoil | 90 Day Systemic and Local Inflammation | 3.3 pg/mL | Standard Deviation 0.5 |
Secondary
Baseline Systemic and Local Inflammation
Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Systemic and Local Inflammation | 3.4 pg/mL | Standard Deviation 0.6 |
| Glutamine/Fishoil | Baseline Systemic and Local Inflammation | 3.1 pg/mL | Standard Deviation 0.8 |