OPTIMen: Optimizing Protein Intake in Older Americans With Mobility Limitations

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01275365
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 92
• Location: 1
• Arms: 4
• Duration (Months): 68.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial in community dwelling, older men, 65 years of age or older, who have mobility limitation and low protein intake. The study will have a 2 X 2 factorial design, which will allow us to investigate the effects of dietary protein intake and testosterone separately and together.

Condition or Disease	Intervention/Treatment	Phase
Mobility Limitation	Drug: Testosterone enanthate; Drug: Testosterone enanthate	Phase 3

Detailed Description

The recommended dietary allowance (RDA) for protein, set at 0.8 grams/kg/day for adult men and women, has engendered debate and many experts advocate protein intakes substantially above the RDA to help maintain muscle anabolism in older individuals. It is not known whether increasing protein intake in older Americans, whose current intake is below the RDA, increases skeletal muscle mass, muscle performance and physical function.

Our first aim is to determine whether administration of 1.3 g/kg/day of protein, compared to the RDA (0.8 g/kg/day), will result in greater improvements in lean body mass, maximal voluntary muscle strength and power, and self-reported and performance-based measures of physical function in older men. Our second aim is to determine whether the gains in lean body mass, maximal voluntary strength and self-reported and performance-based measures of physical function during testosterone administration are greater with 1.3 g protein than with the RDA in older men on a eucaloric diet.

We will conduct a randomized, placebo-controlled, double-blind trial using a 2 X 2 factorial design. Community dwelling men, 65 years or older, who have self-reported mobility limitation, a daily protein intake of <0.8 g/kg/day and no contraindications for testosterone therapy, will be randomly assigned to one of four groups: placebo injections plus protein 0.8 g/kg/day; placebo injections plus protein 1.3 g/kg/day; testosterone enanthate 100 mg weekly plus protein 0.8 g/kg/day; testosterone enanthate 100 mg weekly plus protein 1.3 g/kg/day. Treatment duration will be 6 months. The primary outcome is change in lean body mass from baseline to 6 months, measured by dual energy X-ray absorptiometry. Secondary outcomes include change in maximal voluntary strength in leg and chest press exercises, leg power, self-reported (physical function domain of SF-36) and performance-based measures of physical function (6-min walking distance and speed, stair climbing power, and load carrying), fatigue, well-being and affectivity balance. Safety measures include urinary calcium excretion, hematocrit, prostate specific antigen (PSA) and prostate examination.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Optimizing Protein Intake in Older Americans With Mobility Limitations
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jan 19, 2017
• Actual Study Completion Date: Jan 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Placebo/Low Protein Placebo injections weekly; 0.8 g/kg/day protein
No Intervention: Placebo/High Protein Placebo injections weekly; 1.3 g/kg/day protein
Other: Testosterone/Low Protein Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein	Drug: Testosterone enanthate; Testosterone enanthate 100 mg intramuscularly weekly
Other: Testosterone/High Protein Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein	Drug: Testosterone enanthate; Testosterone enanthate 100 mg intramuscularly weekly

Outcome Measures

Primary Outcome Measures

1. Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA) [6 months from baseline]

   Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)

Secondary Outcome Measures

1. Change of Maximal Voluntary Strength [6 months from baseline]

   Tests of Muscle Performance: (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities.

2. Change of Leg Press Power [6 months from baseline]

   Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig.

3. Change of 6-minute Walking Distance [6 months from baseline]

   Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance

4. Change of Stair Climbing Tests [6 months from baseline]

   Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12.

5. Change of 50-meter Loaded Walking Test [6 months from baseline]

   Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. The test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags. Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.

6. Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36) [6 months from baseline]

   36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36) contains 10 items with the score range of 0-100. Higher score yields better performance.

7. Change of Psychological Well Being Index (PGWBI) [6 months from baseline]

   The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The 22 items are grouped in 6 dimensions. A global score is computed as the sum of all items with range of 0-110. A higher score yields better performance.

8. Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale [6 months from baseline]

   The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.

9. Change of Derogatis Affective Balance Scale (DABS) [6 months from baseline]

   The Derogatis Affects Balance Scale (DABS) is a multidimensional self-report mood and affects inventory comprised of 40 adjective-items using a 5-point Likert style scale. The DABS global scores consist of the Positive Total score (PTOT), Negative Total score (NTOT), where The Positive Affects Total (PTOT) is defined as the sum of all scores on the four positive affects dimensions of joy, contentment, vigor and affection, ranging 0-80. Similarly, the Negative Affects Total (NTOT) is represented as the sum of scores on the four negative dimensions of anxiety, depression, guilt and hostility, ranging 0-80. The Affects Expressiveness Index (AEI) is defined as the sum total of PTOT and NTOT, ranging 0-160. Higher score yields stronger affective intensity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Community-dwelling men 65 years of age or older

2. A score of 3-10 on the short physical performance battery (SPPB)

3. Daily protein intake less than the recommended daily allowance of 0.83 g/kg/day (from 3 24-hour food recalls)

4. Able to give informed consent

Exclusion Criteria:

1. History of prostate or breast cancer

2. American Urological Association [AUA] symptom index score of >19

3. Prostate specific antigen (PSA) >4 ng/ml in White men or >3 ng/ml in Black men

4. Prostate specific antigen (PSA) > 4 ng/ml in non-Black men or >3 ng/ml in Black men. These subjects may be enrolled if they have a negative transrectal biopsy within the past year.

5. Myocardial infarction or stroke within the last 6 months

6. Uncontrolled congestive heart failure, based on the study physician's evaluation

7. Serum creatinine > 2.0 mg/dL; men on any kind of dialysis will be excluded.

8. History of celiac disease, Crohn's disease, or ulcerative colitis

9. History of any malignancy requiring treatment within the previous 2 years, except non-melanic skin cancers. Men with cancers who have not required active treatment within the past two years and who have not had disease recurrence within the past two years may be enrolled at the discretion of the study physician.

10. Neuromuscular diseases: motor neuron diseases, multiple sclerosis, adult muscular dystrophies, and myasthenia gravis

11. History of stroke with residual limb weakness that affected the individual's ability to walk; subjects with history of stroke who do not have residual limb weakness may be enrolled.

12. Schizophrenia, bipolar disorder, or untreated diagnosed depression. Subjects with unipolar depression who are on an antidepressant medication are eligible.

13. TSH levels <0.4 or >5 mlU/L

14. Systolic blood pressure (BP) >160 or diastolic BP >100 mm Hg (average of 2 measurements taken at Visit 1)

15. Hemoglobin A1c >8.0% or taking insulin. Men with diabetes mellitus whose A1C is less than 8.0% or who are not taking insulin will be eligible.

16. Mini-Mental Status Exam [MMSE] <24

17. Body mass index (BMI) less than 20 or greater than 40 kg/m2

18. Not willing to eat all of the following: red meat, eggs, poultry, fish and shellfish

19. Allergy to sesame, peanuts, soy, gluten or shellfish

20. Current alcohol use >21 drinks/week based on self-report

21. Confinement to a wheelchair

22. Use of anabolic therapies (Testosterone, DHEA, androstenedione, rhGH) within the past year

23. Current use of levodopa or anticoagulants

24. Current enrollment in a structured weight management program or participation in any weight intervention studies in the last 90 days

25. Serum ALT and AST greater than 3 x upper limit of normal

26. Hematocrit < 30% or >48%

27. Subject is not able to eat 3 frozen study meals per day for 6 months

28. Subject is unwilling to stop current nutritional supplements

29. Progressive intensive resistance training within 12 weeks of screening

30. Non-compliant with run-in diet and/or supplement

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Shalender Bhasin, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 23, 2016

More Information

Publications

None provided.

• Responsible Party: Shalendar Bhasin, MD, Shalendar Bhasin, MD, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01275365
• Other Study ID Numbers: 2012P001321; 7R01AG037547
• First Posted: Jan 12, 2011
• Last Update Posted: Jul 29, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Shalendar Bhasin, MD, Shalendar Bhasin, MD, Brigham and Women's Hospital: Mobility Limitation; Low Protein Intake; Older Men; Testosterone
• Additional relevant MeSH terms: Mobility Limitation; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate

Study Results

Participant Flow

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Period Title: Overall Study
STARTED	24	24	22	22
COMPLETED	21	21	17	19
NOT COMPLETED	3	3	5	3

Baseline Characteristics

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein	Total
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Total of all reporting groups
Overall Participants	24	24	22	22	92
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.3 (4.2)	73.5 (5.7)	71.0 (3.6)	76.0 (7.9)	73.0 (5.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	24 100%	24 100%	22 100%	22 100%	92 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	24 100%	24 100%	22 100%	22 100%	92 100%
Body weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	95.3 (12.5)	90.2 (15.8)	94.4 (17.6)	87.2 (18.3)	91.8 (16.2)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.1 (4.2)	29.6 (4.6)	31.4 (5.5)	29.0 (5.0)	30.3 (4.9)
Diabetes (Count of Participants)
Count of Participants [Participants]	4 16.7%	4 16.7%	3 13.6%	3 13.6%	14 15.2%

Outcome Measures

1. Primary Outcome

Title	Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)
Description	Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	21	21	17	19
Mean (Standard Error) [kg]	0.14 (0.31)	0.74 (0.33)	4.43 (0.48)	4.13 (0.42)

2. Secondary Outcome

Title	Change of Maximal Voluntary Strength
Description	Tests of Muscle Performance: (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	13	9	14	13
Maximal voluntary strength in leg press	134.6 (46.4)	156.0 (89.1)	201.8 (44.4)	191.4 (38.0)
Maximal voluntary strength in chest press	41.5 (12.3)	16.6 (9.2)	64.5 (11.9)	59.3 (11.3)

3. Secondary Outcome

Title	Change of Leg Press Power
Description	Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	12	9	15	12
Mean (Standard Error) [watts]	26.9 (17.0)	96.9 (19.6)	61.5 (22.2)	81.7 (16.1)

4. Secondary Outcome

Title	Change of 6-minute Walking Distance
Description	Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	16	14	16	18
Mean (Standard Error) [meters]	44.2 (17.9)	49.9 (14.2)	38.2 (21.9)	25.5 (11.5)

5. Secondary Outcome

Title	Change of Stair Climbing Tests
Description	Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	14	11	16	15
Unloaded	50.8 (19.2)	55.4 (14.2)	53.2 (17.5)	4.2 (13.5)
Loaded	56.8 (15.7)	83.7 (28.5)	56.6 (18.8)	26.9 (14.3)

6. Secondary Outcome

Title	Change of 50-meter Loaded Walking Test
Description	Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. The test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags. Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	11	13	15	13
Mean (Standard Error) [meters per second]	0.15 (0.04)	0.11 (0.05)	0.06 (0.05)	0.08 (0.04)

7. Secondary Outcome

Title	Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36)
Description	36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36) contains 10 items with the score range of 0-100. Higher score yields better performance.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	21	21	17	19
Mean (Standard Error) [units on a scale]	-1.4 (3.1)	-5.5 (5.3)	2.1 (2.8)	-2.9 (2.9)

8. Secondary Outcome

Title	Change of Psychological Well Being Index (PGWBI)
Description	The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The 22 items are grouped in 6 dimensions. A global score is computed as the sum of all items with range of 0-110. A higher score yields better performance.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	21	21	17	19
Mean (Standard Error) [units on a scale]	-0.56 (1.53)	1.17 (1.77)	0.32 (2.08)	2.68 (1.58)

9. Secondary Outcome

Title	Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Description	The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	21	21	17	19
Mean (Standard Error) [units on a scale]	0.14 (1.56)	-0.14 (1.41)	-0.53 (1.39)	1.05 (1.16)

10. Secondary Outcome

Title	Change of Derogatis Affective Balance Scale (DABS)
Description	The Derogatis Affects Balance Scale (DABS) is a multidimensional self-report mood and affects inventory comprised of 40 adjective-items using a 5-point Likert style scale. The DABS global scores consist of the Positive Total score (PTOT), Negative Total score (NTOT), where The Positive Affects Total (PTOT) is defined as the sum of all scores on the four positive affects dimensions of joy, contentment, vigor and affection, ranging 0-80. Similarly, the Negative Affects Total (NTOT) is represented as the sum of scores on the four negative dimensions of anxiety, depression, guilt and hostility, ranging 0-80. The Affects Expressiveness Index (AEI) is defined as the sum total of PTOT and NTOT, ranging 0-160. Higher score yields stronger affective intensity.
Time Frame	6 months from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo/Low Protein	Placebo/High Protein	Testosterone/Low Protein	Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein	Placebo injections weekly; 1.3 g/kg/day protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Measure Participants	21	20	17	19
Affects Expressiveness Index (AEI)	0.65 (3.54)	1.45 (1.96)	-0.50 (2.51)	-3.17 (1.99)
Positive Total score (PTOT)	1.38 (2.09)	2.10 (1.70)	0.69 (1.68)	1.89 (1.29)
Negative Total score (NTOT)	-1.50 (2.03)	-0.65 (1.36)	-0.88 (2.85)	-5.53 (1.47)

Adverse Events

Time Frame	6 months
Arm/Group Title	Placebo/Low Protein		Placebo/High Protein		Testosterone/Low Protein		Testosterone/High Protein
Arm/Group Description	Placebo injections weekly; 0.8 g/kg/day protein		Placebo injections weekly; 1.3 g/kg/day protein		Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly		Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
All Cause Mortality
	Placebo/Low Protein		Placebo/High Protein		Testosterone/Low Protein		Testosterone/High Protein
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/22 (0%)		0/22 (0%)
Serious Adverse Events
	Placebo/Low Protein		Placebo/High Protein		Testosterone/Low Protein		Testosterone/High Protein
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/24 (8.3%)		2/24 (8.3%)		0/22 (0%)		1/22 (4.5%)
Injury, poisoning and procedural complications
Fall	0/24 (0%)		1/24 (4.2%)		0/22 (0%)		0/22 (0%)
Nervous system disorders
Dizziness	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		0/22 (0%)
Ischaemic stroke	0/24 (0%)		1/24 (4.2%)		0/22 (0%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Dyspnoea	0/24 (0%)		1/24 (4.2%)		0/22 (0%)		0/22 (0%)
Vascular disorders
Hypotension	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Placebo/Low Protein		Placebo/High Protein		Testosterone/Low Protein		Testosterone/High Protein
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/24 (83.3%)		21/24 (87.5%)		21/22 (95.5%)		15/22 (68.2%)
Blood and lymphatic system disorders
Lymphadenopathy	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Polycythaemia	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Cardiac disorders
Chest pain	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Palpitations	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Pulmonary congestion	0/24 (0%)		2/24 (8.3%)		0/22 (0%)		0/22 (0%)
Ear and labyrinth disorders
Ear discomfort	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Ear infection	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Eye disorders
Cataract	0/24 (0%)		2/24 (8.3%)		0/22 (0%)		0/22 (0%)
Eye irritation	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Gastrointestinal disorders
Constipation	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		4/22 (18.2%)	5
Dental caries	0/24 (0%)		0/24 (0%)		2/22 (9.1%)		0/22 (0%)
Diarrhoea	1/24 (4.2%)		0/24 (0%)		2/22 (9.1%)		2/22 (9.1%)	4
Flatulence, bloating and distension	0/24 (0%)		1/24 (4.2%)		0/22 (0%)		1/22 (4.5%)
Gastrooesophageal reflux disease	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		1/22 (4.5%)
Noninfective gingivitis	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Oropharyngeal pain	0/24 (0%)		1/24 (4.2%)		1/22 (4.5%)		0/22 (0%)
Tooth loss	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Toothache	0/24 (0%)		2/24 (8.3%)		0/22 (0%)		0/22 (0%)
General disorders
Fatigue	1/24 (4.2%)		1/24 (4.2%)		1/22 (4.5%)		0/22 (0%)
Inflammation	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Malaise	0/24 (0%)		1/24 (4.2%)		0/22 (0%)		1/22 (4.5%)
Immune system disorders
Asthma	1/24 (4.2%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Seasonal allergy	1/24 (4.2%)		2/24 (8.3%)		0/22 (0%)		1/22 (4.5%)
Infections and infestations
Bronchitis	1/24 (4.2%)		1/24 (4.2%)		1/22 (4.5%)		0/22 (0%)
Cellulitis	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Conjunctivitis	2/24 (8.3%)		0/24 (0%)		0/22 (0%)		0/22 (0%)
Pheumonia	1/24 (4.2%)		2/24 (8.3%)		0/22 (0%)		0/22 (0%)
Urinary tract infections	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Injury, poisoning and procedural complications
Contusion	1/24 (4.2%)		0/24 (0%)		1/22 (4.5%)		1/22 (4.5%)
Epicodylitis	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Fall	1/24 (4.2%)	2	0/24 (0%)	2	1/22 (4.5%)	2	1/22 (4.5%)	2
Injection site pain	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Joint injury	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Laceration	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Ligament injury	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Ligament sprain	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Limb crushing injury	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Limb injury	1/24 (4.2%)		0/24 (0%)		1/22 (4.5%)		1/22 (4.5%)
Tendon injury	0/24 (0%)		0/24 (0%)		1/22 (4.5%)	2	0/22 (0%)	2
Investigations
Biopsy skin	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Blood glucose increased	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Prostatic specific antigen abnormal	2/24 (8.3%)		2/24 (8.3%)		1/22 (4.5%)		2/22 (9.1%)
Metabolism and nutrition disorders
Diabetes mellitus	1/24 (4.2%)		1/24 (4.2%)		0/22 (0%)		1/22 (4.5%)
Oedema peripheral	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/24 (8.3%)	4	1/24 (4.2%)	2	2/22 (9.1%)	2	2/22 (9.1%)	2
Back pain	6/24 (25%)		1/24 (4.2%)		4/22 (18.2%)		3/22 (13.6%)
Gout	0/24 (0%)		0/24 (0%)		0/22 (0%)		2/22 (9.1%)	4
Muscle spasms	1/24 (4.2%)	2	2/24 (8.3%)	2	2/22 (9.1%)	2	1/22 (4.5%)	2
Muscle strain	3/24 (12.5%)		2/24 (8.3%)		1/22 (4.5%)		1/22 (4.5%)
Muscle tightness	2/24 (8.3%)		0/24 (0%)		0/22 (0%)		0/22 (0%)
Musculoskeletal discomfort	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Musculoskeletal pain	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Musculoskeletal stiffness	0/24 (0%)		3/24 (12.5%)		1/22 (4.5%)		1/22 (4.5%)
Myalgia	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		3/22 (13.6%)
Neck pain	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Pain in extremity	2/24 (8.3%)		1/24 (4.2%)	2	1/22 (4.5%)	2	3/22 (13.6%)	2
Sciatica	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermal cyst	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Nervous system disorders
Balance disorder	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Dizziness	2/24 (8.3%)		0/24 (0%)		0/22 (0%)		3/22 (13.6%)	6
Dizziness postural	0/24 (0%)		0/24 (0%)		0/22 (0%)		2/22 (9.1%)
Dysgeusia	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Gait disturbance	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		1/22 (4.5%)
Head discomfort	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Headache	2/24 (8.3%)		1/24 (4.2%)		0/22 (0%)		2/22 (9.1%)
Psychiatric disorders
Depression	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Renal and urinary disorders
Lower urinary tract symptoms	2/24 (8.3%)		1/24 (4.2%)		1/22 (4.5%)		0/22 (0%)
Nocturia	0/24 (0%)		2/24 (8.3%)		1/22 (4.5%)		1/22 (4.5%)
Polyuria	0/24 (0%)		1/24 (4.2%)		1/22 (4.5%)		4/22 (18.2%)
Proteinuria	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Urine flow decreased	1/24 (4.2%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Reproductive system and breast disorders
Nipple pain	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Prostatic asymmetry	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Prostatitis	2/24 (8.3%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)	2
Cough	3/24 (12.5%)		1/24 (4.2%)		0/22 (0%)		1/22 (4.5%)
Ifluenza	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Musculoskeletal chest pain	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Nasal congestion	1/24 (4.2%)		1/24 (4.2%)		1/22 (4.5%)	2	0/22 (0%)	2
Nasopharyngitis	2/24 (8.3%)		2/24 (8.3%)		2/22 (9.1%)		1/22 (4.5%)
Non-cardiac chest pain	1/24 (4.2%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Rhinitis	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Sinusitis	2/24 (8.3%)	3	0/24 (0%)	3	0/22 (0%)	3	0/22 (0%)	3
Upper respiratory tract infection	3/24 (12.5%)		1/24 (4.2%)		4/22 (18.2%)		3/22 (13.6%)	4
Wheezing	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Skin and subcutaneous tissue disorders
Acne	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		1/22 (4.5%)
Dry skin	2/24 (8.3%)		0/24 (0%)		0/22 (0%)		0/22 (0%)
Pruritus	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Rash	0/24 (0%)		2/24 (8.3%)		0/22 (0%)		1/22 (4.5%)
Rash macular	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Rash pruritic	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Surgical and medical procedures
Cataract operation	0/24 (0%)		0/24 (0%)		1/22 (4.5%)		0/22 (0%)
Vascular disorders
Flushing	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Haemorrhoidal haemorrhage	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Hot flush	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Hypertension	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)
Skin ulcer	0/24 (0%)		0/24 (0%)		0/22 (0%)		1/22 (4.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.