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Optimizing Protein Intake in Older Americans With Mobility Limitations (OPTIMen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01275365
Recruitment Status : Completed
First Posted : January 12, 2011
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Shalendar Bhasin, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Mobility Limitation
Intervention Drug: Testosterone enanthate
Enrollment 92

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein Total
Hide 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 Number of Baseline Participants 24 24 22 22 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 22 participants 22 participants 92 participants
71.3  (4.2) 73.5  (5.7) 71.0  (3.6) 76.0  (7.9) 73.0  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 22 participants 22 participants 92 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
24
 100.0%
24
 100.0%
22
 100.0%
22
 100.0%
92
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 22 participants 22 participants 92 participants
24 24 22 22 92
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 24 participants 24 participants 22 participants 22 participants 92 participants
95.3  (12.5) 90.2  (15.8) 94.4  (17.6) 87.2  (18.3) 91.8  (16.2)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 24 participants 24 participants 22 participants 22 participants 92 participants
31.1  (4.2) 29.6  (4.6) 31.4  (5.5) 29.0  (5.0) 30.3  (4.9)
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 22 participants 22 participants 92 participants
4
  16.7%
4
  16.7%
3
  13.6%
3
  13.6%
14
  15.2%
1.Primary Outcome
Title Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)
Hide Description Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)
Time Frame 6 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 21 21 17 19
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 13 9 14 13
Mean (Standard Error)
Unit of Measure: newton
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
Hide Description Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig.
Time Frame 6 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 12 9 15 12
Mean (Standard Error)
Unit of Measure: 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
Hide Description Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance
Time Frame 6 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 16 14 16 18
Mean (Standard Error)
Unit of Measure: 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
Hide Description Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry.
Time Frame 6 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 14 11 16 15
Mean (Standard Error)
Unit of Measure: watts
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
Hide Description Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry.
Time Frame 6 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 11 13 15 13
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 21 21 17 19
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 21 21 17 19
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 21 21 17 19
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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

Overall Number of Participants Analyzed 21 20 17 19
Mean (Standard Error)
Unit of Measure: units on a scale
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)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo/Low Protein Placebo/High Protein Testosterone/Low Protein Testosterone/High Protein
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)      0/22 (0.00%)      0/22 (0.00%)    
Show Serious Adverse Events Hide 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 (8.33%)      2/24 (8.33%)      0/22 (0.00%)      1/22 (4.55%)    
Cardiac disorders         
Stroke   0/24 (0.00%)  1/24 (4.17%)  2 0/22 (0.00%)  0/22 (0.00%) 
Hypotension   1/24 (4.17%)  0/24 (0.00%)  0/22 (0.00%)  0/22 (0.00%) 
Ear and labyrinth disorders         
Inner ear problem   1/24 (4.17%)  0/24 (0.00%)  0/22 (0.00%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia   0/24 (0.00%)  1/24 (4.17%)  0/22 (0.00%)  0/22 (0.00%) 
COPD Exacerbation   0/24 (0.00%)  0/24 (0.00%)  0/22 (0.00%)  1/22 (4.55%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (83.33%)      21/24 (87.50%)      21/22 (95.45%)      15/22 (68.18%)    
Blood and lymphatic system disorders         
Hematologic/Lymphatic   1/24 (4.17%)  0/24 (0.00%)  1/22 (4.55%)  1/22 (4.55%) 
Cardiac disorders         
Cardiovascular   3/24 (12.50%)  1/24 (4.17%)  1/22 (4.55%)  4/22 (18.18%) 
Endocrine disorders         
Endorine/Metabolic   2/24 (8.33%)  2/24 (8.33%)  0/22 (0.00%)  5/22 (22.73%) 
Gastrointestinal disorders         
Gastrointestinal   5/24 (20.83%)  4/24 (16.67%)  4/22 (18.18%)  6/22 (27.27%) 
General disorders         
Other   11/24 (45.83%)  10/24 (41.67%)  6/22 (27.27%)  4/22 (18.18%) 
Infections and infestations         
Infectious Disease   10/24 (41.67%)  7/24 (29.17%)  7/22 (31.82%)  2/22 (9.09%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal   14/24 (58.33%)  10/24 (41.67%)  11/22 (50.00%)  11/22 (50.00%) 
Nervous system disorders         
Neurologic   4/24 (16.67%)  2/24 (8.33%)  0/22 (0.00%)  4/22 (18.18%) 
Psychiatric disorders         
Psychiatric   2/24 (8.33%)  0/24 (0.00%)  0/22 (0.00%)  1/22 (4.55%) 
Renal and urinary disorders         
Genital/Urinary   7/24 (29.17%)  7/24 (29.17%)  6/22 (27.27%)  6/22 (27.27%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory   8/24 (33.33%)  9/24 (37.50%)  3/22 (13.64%)  6/22 (27.27%) 
Skin and subcutaneous tissue disorders         
Dermatologic   4/24 (16.67%)  4/24 (16.67%)  5/22 (22.73%)  6/22 (27.27%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Shalendar Bhasin, MD
Organization: Brigham and Women's Hospital
Phone: 617-525-9040
Responsible Party: Shalendar Bhasin, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01275365     History of Changes
Other Study ID Numbers: AG037547
First Submitted: January 11, 2011
First Posted: January 12, 2011
Results First Submitted: January 19, 2018
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018