Optimizing Protein Intake in Older Americans With Mobility Limitations

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