Optimizing Protein Intake in Older Americans With Mobility Limitations
Condition: Mobility Limitation
MeSH terms: Mobility Limitation
Intervention: Testosterone enanthate; Testosterone enanthate
Intervention description: Testosterone enanthate 100 mg intramuscularly weekly; Testosterone enanthate 100 mg intramuscularly weekly
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: Male
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Mobility Limitation; Low Protein Intake; Older Men; Testosterone

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.
    

Eligibility criteria:

        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