ClinicalTrials.gov
ClinicalTrials.gov Menu

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo/Low Protein Placebo injections weekly; 0.8 g/kg/day protein
Placebo/High Protein Placebo injections weekly; 1.3 g/kg/day protein
Testosterone/Low Protein

Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein

Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly

Testosterone/High Protein

Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein

Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly


Participant Flow:   Overall Study
    Placebo/Low Protein   Placebo/High Protein   Testosterone/Low Protein   Testosterone/High Protein
STARTED   24   24   22   22 
COMPLETED   21   21   17   19 
NOT COMPLETED   3   3   5   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo/Low Protein Placebo injections weekly; 0.8 g/kg/day protein
Placebo/High Protein Placebo injections weekly; 1.3 g/kg/day protein
Testosterone/Low Protein

Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein

Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly

Testosterone/High Protein

Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein

Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly

Total Total of all reporting groups

Baseline Measures
   Placebo/Low Protein   Placebo/High Protein   Testosterone/Low Protein   Testosterone/High Protein   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   22   22   92 
Age 
[Units: Years]
Mean (Standard Deviation)
         
Participants Analyzed   24   24   22   22   92 
   71.3  (4.2)   73.5  (5.7)   71.0  (3.6)   76.0  (7.9)   73.0  (5.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed   24   24   22   22   92 
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] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   0   0   0   0   0 
               0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
         
United States           
Participants Analyzed   24   24   22   22   92 
United States   24   24   22   22   92 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
         
Participants Analyzed   24   24   22   22   92 
   95.3  (12.5)   90.2  (15.8)   94.4  (17.6)   87.2  (18.3)   91.8  (16.2) 
Body Mass Index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation)
         
Participants Analyzed   24   24   22   22   92 
   31.1  (4.2)   29.6  (4.6)   31.4  (5.5)   29.0  (5.0)   30.3  (4.9) 
Diabetes 
[Units: Participants]
Count of Participants
         
Participants Analyzed   24   24   22   22   92 
   4   4   3   3   14 


  Outcome Measures

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

2.  Secondary:   Change of Maximal Voluntary Strength   [ Time Frame: 6 months from baseline ]

3.  Secondary:   Change of Leg Press Power   [ Time Frame: 6 months from baseline ]

4.  Secondary:   Change of 6-minute Walking Distance   [ Time Frame: 6 months from baseline ]

5.  Secondary:   Change of Stair Climbing Tests   [ Time Frame: 6 months from baseline ]

6.  Secondary:   Change of 50-meter Loaded Walking Test   [ Time Frame: 6 months from baseline ]

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

8.  Secondary:   Change of Psychological Well Being Index (PGWBI)   [ Time Frame: 6 months from baseline ]

9.  Secondary:   Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale   [ Time Frame: 6 months from baseline ]

10.  Secondary:   Change of Derogatis Affective Balance Scale (DABS)   [ Time Frame: 6 months from baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Sbhasin@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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