Optimizing Protein Intake in Older Americans With Mobility Limitations

• Status: Completed
• Trial end date: 2017-01-19
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute on Aging (NIA)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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