Trial Outcomes & Findings for Mechanistic Approach to Preventing Atrophy and Restoring Function in Older Adults (NCT NCT02145949)
NCT ID: NCT02145949
Last Updated: 2024-07-23
Results Overview
MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra to measure muscle volume in Arbitrary Units (AU). Low values = low volume. High values = higher volume. Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region. MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra (UO Lewis Center for Neuroimaging). Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
6 weeks after baseline
Results posted on
2024-07-23
Participant Flow
Both aims will target older adults, ages 50 - 80 years for have elected to undergo primary total knee arthroplasty performed at PeaceHealth Sacred Heart Medical Center at RiverBend by Dr. Jewett, Lantz, Mohler or Shah. Between 2005-2010, they performed a total 2,066 TKAs. Of those, 1,406 of the patients were between 50-80 years of age (68%). A total of 120 subjects will be enrolled in the two study aims.
Participant milestones
| Measure |
Essential Amino Acids (EAA)
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
36
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanistic Approach to Preventing Atrophy and Restoring Function in Older Adults
Baseline characteristics by cohort
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
64.95 years
STANDARD_DEVIATION 5.90 • n=5 Participants
|
63.90 years
STANDARD_DEVIATION 5.37 • n=7 Participants
|
64.41 years
STANDARD_DEVIATION 5.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
MRI Quadriceps Involved Leg
|
48.66 AU
STANDARD_DEVIATION 14.62 • n=5 Participants
|
44.81 AU
STANDARD_DEVIATION 13.82 • n=7 Participants
|
46.63 AU
STANDARD_DEVIATION 14.14 • n=5 Participants
|
|
MRI Quadriceps Contralateral Leg
|
55.49 AU
STANDARD_DEVIATION 16.43 • n=5 Participants
|
49.98 AU
STANDARD_DEVIATION 13.64 • n=7 Participants
|
52.59 AU
STANDARD_DEVIATION 15.08 • n=5 Participants
|
|
MRI Hamstrings Involved Leg
|
69.32 AU
STANDARD_DEVIATION 17.65 • n=5 Participants
|
63.86 AU
STANDARD_DEVIATION 14.90 • n=7 Participants
|
66.52 AU
STANDARD_DEVIATION 16.32 • n=5 Participants
|
|
MRI Hamstrings Contralateral Leg
|
69.37 AU
STANDARD_DEVIATION 18.25 • n=5 Participants
|
63.64 AU
STANDARD_DEVIATION 14.88 • n=7 Participants
|
66.43 AU
STANDARD_DEVIATION 16.64 • n=5 Participants
|
|
Daily Physical Activity
|
408.15 kcal/day
STANDARD_DEVIATION 192.47 • n=5 Participants
|
319.71 kcal/day
STANDARD_DEVIATION 254.78 • n=7 Participants
|
361.60 kcal/day
STANDARD_DEVIATION 228.82 • n=5 Participants
|
|
Handgrip Strength
|
29.95 kg
STANDARD_DEVIATION 10.42 • n=5 Participants
|
28.35 kg
STANDARD_DEVIATION 8.44 • n=7 Participants
|
28.64 kg
STANDARD_DEVIATION 9.34 • n=5 Participants
|
|
Short Physical Performance Battery
|
3.89 units on a scale
STANDARD_DEVIATION 0.32 • n=5 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 0.00 • n=7 Participants
|
3.95 units on a scale
STANDARD_DEVIATION 0.22 • n=5 Participants
|
|
Timed Up and Go
|
9.88 seconds
STANDARD_DEVIATION 2.02 • n=5 Participants
|
11.40 seconds
STANDARD_DEVIATION 3.05 • n=7 Participants
|
10.66 seconds
STANDARD_DEVIATION 2.68 • n=5 Participants
|
|
4-Meter Walk
|
3.89 seconds
STANDARD_DEVIATION 0.32 • n=5 Participants
|
3.80 seconds
STANDARD_DEVIATION 0.41 • n=7 Participants
|
3.85 seconds
STANDARD_DEVIATION 0.37 • n=5 Participants
|
|
Stair Climb Up
|
8.09 seconds
STANDARD_DEVIATION 2.40 • n=5 Participants
|
9.45 seconds
STANDARD_DEVIATION 4.92 • n=7 Participants
|
8.79 seconds
STANDARD_DEVIATION 3.91 • n=5 Participants
|
|
Stair Climb Down
|
8.03 seconds
STANDARD_DEVIATION 2.92 • n=5 Participants
|
10.70 seconds
STANDARD_DEVIATION 4.74 • n=7 Participants
|
9.40 seconds
STANDARD_DEVIATION 4.13 • n=5 Participants
|
|
6-Minute Walk
|
511.10 meters
STANDARD_DEVIATION 77.29 • n=5 Participants
|
488.30 meters
STANDARD_DEVIATION 101.96 • n=7 Participants
|
499.41 meters
STANDARD_DEVIATION 90.34 • n=5 Participants
|
|
KOOS Symptoms
|
54.13 units on a scale
STANDARD_DEVIATION 18.98 • n=5 Participants
|
50.00 units on a scale
STANDARD_DEVIATION 16.31 • n=7 Participants
|
52.01 units on a scale
STANDARD_DEVIATION 17.55 • n=5 Participants
|
|
KOOS Pain
|
51.18 units on a scale
STANDARD_DEVIATION 15.73 • n=5 Participants
|
53.06 units on a scale
STANDARD_DEVIATION 14.56 • n=7 Participants
|
52.14 units on a scale
STANDARD_DEVIATION 14.97 • n=5 Participants
|
|
KOOS Function Daily Living
|
66.01 units on a scale
STANDARD_DEVIATION 15.00 • n=5 Participants
|
60.67 units on a scale
STANDARD_DEVIATION 15.60 • n=7 Participants
|
63.34 units on a scale
STANDARD_DEVIATION 15.34 • n=5 Participants
|
|
KOOS Function Sports/Recreation
|
27.90 units on a scale
STANDARD_DEVIATION 20.43 • n=5 Participants
|
30.00 units on a scale
STANDARD_DEVIATION 26.36 • n=7 Participants
|
28.97 units on a scale
STANDARD_DEVIATION 23.37 • n=5 Participants
|
|
KOOS Knee-Related Quality of Life
|
30.26 units on a scale
STANDARD_DEVIATION 13.70 • n=5 Participants
|
24.01 units on a scale
STANDARD_DEVIATION 17.46 • n=7 Participants
|
27.14 units on a scale
STANDARD_DEVIATION 15.80 • n=5 Participants
|
|
PHQ-9
|
3.42 units on a scale
STANDARD_DEVIATION 4.57 • n=5 Participants
|
4.10 units on a scale
STANDARD_DEVIATION 3.78 • n=7 Participants
|
3.77 units on a scale
STANDARD_DEVIATION 4.15 • n=5 Participants
|
|
PCS12
|
33.17 units on a scale
STANDARD_DEVIATION 9.55 • n=5 Participants
|
33.41 units on a scale
STANDARD_DEVIATION 9.08 • n=7 Participants
|
33.30 units on a scale
STANDARD_DEVIATION 9.15 • n=5 Participants
|
|
MCS12
|
55.48 units on a scale
STANDARD_DEVIATION 10.60 • n=5 Participants
|
57.23 units on a scale
STANDARD_DEVIATION 7.26 • n=7 Participants
|
56.43 units on a scale
STANDARD_DEVIATION 8.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra to measure muscle volume in Arbitrary Units (AU). Low values = low volume. High values = higher volume. Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region. MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra (UO Lewis Center for Neuroimaging). Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
MRI Quadriceps Involved Leg
|
43.87 AU
Standard Deviation 12.08
|
38.31 AU
Standard Deviation 10.69
|
PRIMARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra to measure muscle volume in Arbitrary Units (AU). Low values = low volume. High values = higher volume. Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region. MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra (UO Lewis Center for Neuroimaging). Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
MRI Quadriceps Contralateral Leg
|
54.41 AU
Standard Deviation 15.50
|
46.44 AU
Standard Deviation 13.16
|
PRIMARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra to measure muscle volume in Arbitrary Units (AU). Low values = low volume. High values = higher volume. Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region. MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra (UO Lewis Center for Neuroimaging). Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
MRI Hamstrings Involved Leg
|
63.76 AU
Standard Deviation 14.88
|
55.93 AU
Standard Deviation 13.01
|
PRIMARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra to measure muscle volume in Arbitrary Units (AU). Low values = low volume. High values = higher volume. Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region. MRI of the bilateral lower extremities was performed utilizing a Siemens 3T Skyra (UO Lewis Center for Neuroimaging). Dixon pulse sequence optimized for imaging near metal implants was used to capture T1-weighted, water, and fat images of the mid-thigh region.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
MRI Hamstrings Contralateral Leg
|
67.50 AU
Standard Deviation 16.33
|
58.75 AU
Standard Deviation 13.65
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Average daily calories expended in physical activity calculated from accelerometer data
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
Daily Physical Activity
|
265.67 kcal/day
Standard Deviation 151.43
|
196.54 kcal/day
Standard Deviation 80.34
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Maximum isometric strength of the hand and forearm muscles measured by a handgrip dynamometer
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
Handgrip Strength
|
30.74 kg
Standard Deviation 10.61
|
28.03 kg
Standard Deviation 8.37
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Short Physical Performance Battery. Minimum = 0. Maximum = 11. 0 representing extreme problems and 11 is no problems. The higher the score the better the outcome.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
Short Physical Performance Battery
|
3.95 units on a scale
Standard Deviation 0.23
|
3.90 units on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Time from a seated position to walk forward 3 meters, turn around, walk back 3 meters, and sit down again
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
Timed Up and Go
|
9.87 seconds
Standard Deviation 1.92
|
10.90 seconds
Standard Deviation 3.71
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Time from a standing position to walk 4 meters through the finish line
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
4-Meter Walk
|
3.89 seconds
Standard Deviation 0.32
|
3.90 seconds
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Time to climb up 11 steps
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
Stair Climb Up
|
7.95 seconds
Standard Deviation 2.80
|
8.64 seconds
Standard Deviation 3.40
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Time to climb down 11 steps
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
Stair Climb Down
|
8.12 seconds
Standard Deviation 3.22
|
9.53 seconds
Standard Deviation 4.57
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Total distance walked in 6 minutes
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
6-Minute Walk
|
464.56 meters
Standard Deviation 139.40
|
477.02 meters
Standard Deviation 103.96
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Knee Injury and Osteoarthritis Outcome Score measuring patients' overall opinions about knee and associated problems. Minimum = 0. Maximum = 100. 0 representing extreme problems and 100 representing no problems.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
KOOS Symptoms
|
68.80 scores on a scale
Standard Deviation 12.36
|
56.99 scores on a scale
Standard Deviation 15.70
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Knee Injury and Osteoarthritis Outcome Score measuring patients' opinions about knee-specific pain; 0-100 Minimum = 0. Maximum = 100. 0 representing extreme problems and 100 representing no problems.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
KOOS Pain
|
68.71 scores on a scale
Standard Deviation 8.97
|
64.77 scores on a scale
Standard Deviation 14.87
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Knee Injury and Osteoarthritis Outcome Score measuring patients' opinions about knee-specific function in daily life; 0-100 Minimum = 0. Maximum = 100. 0 representing extreme problems and 100 representing no problems.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
KOOS Function Daily Living
|
81.41 score on a scale
Standard Deviation 10.52
|
76.16 score on a scale
Standard Deviation 12.10
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Knee Injury and Osteoarthritis Outcome Score measuring patients' opinions about knee-specific function in sport and recreation; 0-100 Minimum = 0. Maximum = 100. 0 representing extreme problems and 100 representing no problems.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
KOOS Function Sports/Recreation
|
44.21 score on a scale
Standard Deviation 27.70
|
37.90 score on a scale
Standard Deviation 22.87
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Knee Injury and Osteoarthritis Outcome Score measuring patients' opinions about knee-related quality of life; 0-100 Minimum = 0. Maximum = 100. 0 representing extreme problems and 100 representing no problems.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
KOOS Knee-Related Quality of Life
|
51.74 score on a scale
Standard Deviation 17.78
|
50.33 score on a scale
Standard Deviation 16.33
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Patient Health Questionnaire depression module measuring depression symptom severity; 0-27. 0 is minimum and 27 is maximum. Lower score is less depression symptoms. Higher score is high depression symptoms.
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
PHQ-9
|
4.68 score on a scale
Standard Deviation 3.70
|
3.68 score on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Veterans Rand 12-item Health Survey Physical Component Summary norm-referenced score reflecting physical health-related quality of life. Minimum = 0. Maximum = 100. 0 representing extreme problems and 100
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
PCS12
|
37.55 score on a scale
Standard Deviation 8.83
|
35.48 score on a scale
Standard Deviation 7.27
|
SECONDARY outcome
Timeframe: 6 weeks after baselinePopulation: enrolled participants who completed the study
Veterans Rand 12-item Health Survey Mental Component Summary norm-referenced score reflecting mental health-related quality of life. Minimum = 0. Maximum = 100. 0 representing extreme problems and 100
Outcome measures
| Measure |
Essential Amino Acids (EAA)
n=19 Participants
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=20 Participants
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
MCS12
|
52.11 score on a scale
Standard Deviation 11.01
|
54.76 score on a scale
Standard Deviation 11.60
|
Adverse Events
Essential Amino Acids (EAA)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Alanine)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Essential Amino Acids (EAA)
n=31 participants at risk
Aim 1: Twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 2.2 g (11% of total); isoleucine, 2.0 g (10%); leucine, 3.6 g (18%); lysine, 3.2 g (16%); methionine, 0.6 g (3%); phenylalanine, 3.2 g (16%); threonine, 2.8 g (14%); and valine, 2.4 g (12%).
Aim 2: Twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA.
Supplement composition for the EAAs: histidine, 1.28 g (5% of total); isoleucine, 1.8 g (8%); leucine, 7.4 g (32%); lysine, 3.6 g (15%); methionine, 1.76 g (8%); phenylalanine, 3.1 g (13%); threonine, 1.9 g (8%); valine, 2.08 g (9%); and tryptophan, 0.5 g (2%).
Essential Amino Acids (EAA): Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
Placebo (Alanine)
n=36 participants at risk
Aim 1: Twice-daily ingestion of 20 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 20 g (100%) alanine.
Aim 2: Twice-daily ingestion of 23 g of Alanine (Non-essential amino acid) for 1 wk before through 6 wk after TKA.
The placebo supplement consists of 23 g (100%) alanine.
Placebo (Alanine): Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery \[surgery = primary total knee arthroplasty\]
|
|---|---|---|
|
General disorders
Nausea
|
6.5%
2/31 • Number of events 2 • baseline to 6 weeks
The study assessed the effectiveness of FDA-approved over-the-counter supplements, which did not cause any participants to be at risk for Serious Adverse Events, All-Cause Mortality, and Other Adverse Events.
|
11.1%
4/36 • Number of events 4 • baseline to 6 weeks
The study assessed the effectiveness of FDA-approved over-the-counter supplements, which did not cause any participants to be at risk for Serious Adverse Events, All-Cause Mortality, and Other Adverse Events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place