Trial Outcomes & Findings for Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure (NCT NCT01534663)
NCT ID: NCT01534663
Last Updated: 2020-12-22
Results Overview
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)).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
31 participants
Primary outcome timeframe
Baseline
Results posted on
2020-12-22
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 2 • n=5 Participants
|
59 years
STANDARD_DEVIATION 3 • n=7 Participants
|
59 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineFor 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)).
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Knee: Extension
|
177 Percent
Standard Deviation 18
|
196 Percent
Standard Deviation 10
|
|
Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Knee: Flexion
|
76 Percent
Standard Deviation 6
|
90 Percent
Standard Deviation 5
|
|
Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Elbow: Extension
|
65 Percent
Standard Deviation 6
|
59 Percent
Standard Deviation 4
|
|
Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Elbow: Flexion
|
74 Percent
Standard Deviation 7
|
71 Percent
Standard Deviation 4
|
PRIMARY outcome
Timeframe: 90 DaysFor 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)).
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Knee: Extension
|
200 Percent
Standard Deviation 20
|
206 Percent
Standard Deviation 11
|
|
90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Knee: Flexion
|
90 Percent
Standard Deviation 8
|
90 Percent
Standard Deviation 5
|
|
90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Elbow: Extension
|
64 Percent
Standard Deviation 6
|
61 Percent
Standard Deviation 4
|
|
90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
Elbow: Flexion
|
74 Percent
Standard Deviation 6
|
74 Percent
Standard Deviation 4
|
PRIMARY outcome
Timeframe: BaselineFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Knee: Extension, 5 repetitions
|
147 Percent
Standard Deviation 17
|
153 Percent
Standard Deviation 8
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Knee: Flexion, 5 repetitions
|
61 Percent
Standard Deviation 6
|
70 Percent
Standard Deviation 5
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Elbow: Extension, 5 repetitions
|
46 Percent
Standard Deviation 5
|
42 Percent
Standard Deviation 3
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Elbow: Flexion, 5 repetitions
|
61 Percent
Standard Deviation 6
|
54 Percent
Standard Deviation 3
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Knee: Extension, 25 repetitions
|
103 Percent
Standard Deviation 10
|
105 Percent
Standard Deviation 7
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Knee: Flexion, 25 repetitions
|
55 Percent
Standard Deviation 5
|
96 Percent
Standard Deviation 33
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Elbow: Extension, 25 repetitions
|
37 Percent
Standard Deviation 3
|
35 Percent
Standard Deviation 2
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Elbow: Flexion, 25 repetitions
|
56 Percent
Standard Deviation 5
|
50 Percent
Standard Deviation 3
|
PRIMARY outcome
Timeframe: 90 DaysFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Knee: Extension, 5 repetitions
|
173 Percent
Standard Deviation 20
|
160 Percent
Standard Deviation 9
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Knee: Flexion, 5 repetitions
|
76 Percent
Standard Deviation 9
|
77 Percent
Standard Deviation 4
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Elbow: Extension, 5 repetitions
|
48 Percent
Standard Deviation 5
|
46 Percent
Standard Deviation 2
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Elbow: Flexion, 5 repetitions
|
56 Percent
Standard Deviation 4
|
57 Percent
Standard Deviation 3
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Knee: Extension, 25 repetitions
|
115 Percent
Standard Deviation 10
|
108 Percent
Standard Deviation 6
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Knee: Flexion, 25 repetitions
|
58 Percent
Standard Deviation 4
|
67 Percent
Standard Deviation 3
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Elbow: Extension, 25 repetitions
|
38 Percent
Standard Deviation 4
|
36 Percent
Standard Deviation 2
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
Elbow: Flexion, 25 repetitions
|
55 Percent
Standard Deviation 4
|
51 Percent
Standard Deviation 3
|
PRIMARY outcome
Timeframe: BaselineFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Knee: Extension, 5 repetitions
|
132 Percent
Standard Deviation 15
|
137 Percent
Standard Deviation 8
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Knee: Flexion, 5 repetitions
|
61 Percent
Standard Deviation 9
|
70 Percent
Standard Deviation 6
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Elbow: Extension, 5 repetitions
|
51 Percent
Standard Deviation 6
|
47 Percent
Standard Deviation 4
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Elbow: Flexion, 5 repetitions
|
70 Percent
Standard Deviation 7
|
65 Percent
Standard Deviation 4
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Knee: Extension, 25 repetitions
|
100 Percent
Standard Deviation 11
|
102 Percent
Standard Deviation 7
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Knee: Flexion, 25 repetitions
|
41 Percent
Standard Deviation 6
|
46 Percent
Standard Deviation 6
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Elbow: Extension, 25 repetitions
|
38 Percent
Standard Deviation 4
|
36 Percent
Standard Deviation 3
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Elbow: Flexion, 25 repetitions
|
63 Percent
Standard Deviation 6
|
55 Percent
Standard Deviation 3
|
PRIMARY outcome
Timeframe: 90 DaysFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Knee: Extension, 5 repetitions
|
157 Percent
Standard Deviation 17
|
149 Percent
Standard Deviation 9
|
|
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Knee: Flexion, 5 repetitions
|
78 Percent
Standard Deviation 12
|
80 Percent
Standard Deviation 5
|
|
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Elbow: Extension, 5 repetitions
|
54 Percent
Standard Deviation 6
|
54 Percent
Standard Deviation 3
|
|
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Elbow: Flexion, 5 repetitions
|
68 Percent
Standard Deviation 5
|
71 Percent
Standard Deviation 4
|
|
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Knee: Extension, 25 repetitions
|
111 Percent
Standard Deviation 11
|
108 Percent
Standard Deviation 7
|
|
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Knee: Flexion, 25 repetitions
|
51 Percent
Standard Deviation 6
|
55 Percent
Standard Deviation 4
|
|
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Elbow: Extension, 25 repetitions
|
41 Percent
Standard Deviation 4
|
39 Percent
Standard Deviation 2
|
|
90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
Elbow: Flexion, 25 repetitions
|
60 Percent
Standard Deviation 5
|
58 Percent
Standard Deviation 3
|
PRIMARY outcome
Timeframe: BaselineFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Knee: Extension, 5 repetitions
|
477 Joules
Standard Deviation 64
|
537 Joules
Standard Deviation 50
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Knee: Flexion, 5 repetitions
|
209 Joules
Standard Deviation 35
|
264 Joules
Standard Deviation 36
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Elbow: Extension, 5 repetitions
|
189 Joules
Standard Deviation 23
|
184 Joules
Standard Deviation 19
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Elbow: Flexion, 5 repetitions
|
280 Joules
Standard Deviation 35
|
261 Joules
Standard Deviation 22
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Knee: Extension, 25 repetitions
|
1551 Joules
Standard Deviation 200
|
1776 Joules
Standard Deviation 185
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Knee: Flexion, 25 repetitions
|
552 Joules
Standard Deviation 102
|
742 Joules
Standard Deviation 118
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Elbow: Extension, 25 repetitions
|
590 Joules
Standard Deviation 72
|
612 Joules
Standard Deviation 65
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
Elbow: Flexion, 25 repetitions
|
1108 Joules
Standard Deviation 141
|
992 Joules
Standard Deviation 74
|
PRIMARY outcome
Timeframe: 90 DaysFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Knee: Extension, 5 repetitions
|
586 Joules
Standard Deviation 69
|
603 Joules
Standard Deviation 51
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Knee: Flexion, 5 repetitions
|
277 Joules
Standard Deviation 44
|
319 Joules
Standard Deviation 33
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Elbow: Extension, 5 repetitions
|
209 Joules
Standard Deviation 26
|
193 Joules
Standard Deviation 18
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Elbow: Flexion, 5 repetitions
|
272 Joules
Standard Deviation 27
|
283 Joules
Standard Deviation 15
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Knee: Extension, 25 repetitions
|
1806 Joules
Standard Deviation 176
|
1816 Joules
Standard Deviation 168
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Knee: Flexion, 25 repetitions
|
765 Joules
Standard Deviation 99
|
813 Joules
Standard Deviation 99
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Elbow: Extension, 25 repetitions
|
655 Joules
Standard Deviation 83
|
598 Joules
Standard Deviation 50
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
Elbow: Flexion, 25 repetitions
|
1079 Joules
Standard Deviation 118
|
987 Joules
Standard Deviation 55
|
PRIMARY outcome
Timeframe: BaselineFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Knee: Extension, 5 repetitions
|
65 Watts
Standard Deviation 10
|
75 Watts
Standard Deviation 33
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Knee: Flexion, 5 repetitions
|
26 Watts
Standard Deviation 5
|
33 Watts
Standard Deviation 5
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Elbow: Extension, 5 repetitions
|
24 Watts
Standard Deviation 3
|
23 Watts
Standard Deviation 3
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Elbow: Flexion, 5 repetitions
|
35 Watts
Standard Deviation 4
|
32 Watts
Standard Deviation 3
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Knee: Extension, 25 repetitions
|
106 Watts
Standard Deviation 14
|
121 Watts
Standard Deviation 13
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Knee: Flexion, 25 repetitions
|
26 Watts
Standard Deviation 7
|
46 Watts
Standard Deviation 7
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Elbow: Extension, 25 repetitions
|
37 Watts
Standard Deviation 5
|
38 Watts
Standard Deviation 5
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
Elbow: Flexion, 25 repetitions
|
64 Watts
Standard Deviation 9
|
57 Watts
Standard Deviation 5
|
PRIMARY outcome
Timeframe: 90 DaysFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Knee: Extension, 5 repetitions
|
80 Watts
Standard Deviation 9
|
84 Watts
Standard Deviation 7
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Knee: Flexion, 5 repetitions
|
37 Watts
Standard Deviation 6
|
41 Watts
Standard Deviation 5
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Elbow: Extension, 5 repetitions
|
26 Watts
Standard Deviation 3
|
25 Watts
Standard Deviation 2
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Elbow: Flexion, 5 repetitions
|
34 Watts
Standard Deviation 4
|
34 Watts
Standard Deviation 2
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Knee: Extension, 25 repetitions
|
128 Watts
Standard Deviation 13
|
140 Watts
Standard Deviation 15
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Knee: Flexion, 25 repetitions
|
50 Watts
Standard Deviation 7
|
56 Watts
Standard Deviation 7
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Elbow: Extension, 25 repetitions
|
40 Watts
Standard Deviation 6
|
36 Watts
Standard Deviation 4
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
Elbow: Flexion, 25 repetitions
|
62 Watts
Standard Deviation 8
|
57 Watts
Standard Deviation 4
|
PRIMARY outcome
Timeframe: BaselineFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Knee: Extension, 5 repetitions
|
526 msec
Standard Deviation 44
|
494 msec
Standard Deviation 27
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Knee: Flexion, 5 repetitions
|
828 msec
Standard Deviation 104
|
945 msec
Standard Deviation 84
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Elbow: Extension, 5 repetitions
|
426 msec
Standard Deviation 50
|
344 msec
Standard Deviation 26
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Elbow: Flexion, 5 repetitions
|
806 msec
Standard Deviation 89
|
1003 msec
Standard Deviation 76
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Knee: Extension, 25 repetitions
|
195 msec
Standard Deviation 12
|
212 msec
Standard Deviation 27
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Knee: Flexion, 25 repetitions
|
399 msec
Standard Deviation 61
|
546 msec
Standard Deviation 11
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Elbow: Extension, 25 repetitions
|
376 msec
Standard Deviation 58
|
417 msec
Standard Deviation 50
|
|
Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Elbow: Flexion, 25 repetitions
|
435 msec
Standard Deviation 52
|
426 msec
Standard Deviation 42
|
PRIMARY outcome
Timeframe: 90 DaysFor 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Knee: Extension, 5 repetitions
|
404 msec
Standard Deviation 37
|
456 msec
Standard Deviation 27
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Knee: Flexion, 5 repetitions
|
729 msec
Standard Deviation 45
|
780 msec
Standard Deviation 93
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Elbow: Extension, 5 repetitions
|
429 msec
Standard Deviation 65
|
469 msec
Standard Deviation 45
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Elbow: Flexion, 5 repetitions
|
808 msec
Standard Deviation 77
|
996 msec
Standard Deviation 80
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Knee: Extension, 25 repetitions
|
186 msec
Standard Deviation 12
|
177 msec
Standard Deviation 12
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Knee: Flexion, 25 repetitions
|
366 msec
Standard Deviation 53
|
507 msec
Standard Deviation 32
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Elbow: Extension, 25 repetitions
|
417 msec
Standard Deviation 54
|
314 msec
Standard Deviation 47
|
|
90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
Elbow: Flexion, 25 repetitions
|
420 msec
Standard Deviation 48
|
426 msec
Standard Deviation 43
|
PRIMARY outcome
Timeframe: Baseline to 90 DaysPeak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET).
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
Percent Change in Peak Effort Oxygen Consumption
|
7.9 Percent
Standard Deviation 4.7
|
0.1 Percent
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: BaselineSystemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
Baseline Systemic and Local Inflammation
|
3.4 pg/mL
Standard Deviation 0.6
|
3.1 pg/mL
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 90 DaysSystemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL
Outcome measures
| Measure |
Placebo
n=12 Participants
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.
|
Glutamine/Fishoil
n=14 Participants
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.
|
|---|---|---|
|
90 Day Systemic and Local Inflammation
|
2.5 pg/mL
Standard Deviation 0.4
|
3.3 pg/mL
Standard Deviation 0.5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Glutamine/Fishoil
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
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.
|
Glutamine/Fishoil
n=14 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • 90 Days
|
7.1%
1/14 • 90 Days
|
Additional Information
Christian Schulze, MD, PhD
University Hospital Jena
Phone: 03641-9 32 41 04
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place