Intervention: TESTOSTERONE ENANTHATE
Trial phase: Phase 3
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](OC(=O)CCCCCC)CC[C@@]21[H]
Sex: Male
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein

Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
Eligibility criteria:
Inclusion Criteria:

Community-dwelling men 65 years of age or older
A score of 3-10 on the short physical performance battery (SPPB)
Daily protein intake less than the recommended daily allowance of 0.83 g/kg/day (from 3 24-hour food recalls)
Able to give informed consent

Exclusion Criteria:

History of prostate or breast cancer
American Urological Association [AUA] symptom index score of >19
Prostate specific antigen (PSA) >4 ng/ml in White men or >3 ng/ml in Black men
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.
Myocardial infarction or stroke within the last 6 months
Uncontrolled congestive heart failure, based on the study physician's evaluation
Serum creatinine > 2.0 mg/dL; men on any kind of dialysis will be excluded.
History of celiac disease, Crohn's disease, or ulcerative colitis
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.
Neuromuscular diseases: motor neuron diseases, multiple sclerosis, adult muscular dystrophies, and myasthenia gravis
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.
Schizophrenia, bipolar disorder, or untreated diagnosed depression. Subjects with unipolar depression who are on an antidepressant medication are eligible.
TSH levels <0.4 or >5 mlU/L
Systolic blood pressure (BP) >160 or diastolic BP >100 mm Hg (average of 2 measurements taken at Visit 1)
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.
Mini-Mental Status Exam [MMSE] <24
Body mass index (BMI) less than 20 or greater than 40 kg/m2
Not willing to eat all of the following: red meat, eggs, poultry, fish and shellfish
Allergy to sesame, peanuts, soy, gluten or shellfish
Current alcohol use >21 drinks/week based on self-report
Confinement to a wheelchair
Use of anabolic therapies (Testosterone, DHEA, androstenedione, rhGH) within the past year
Current use of levodopa or anticoagulants
Current enrollment in a structured weight management program or participation in any weight intervention studies in the last 90 days
Serum ALT and AST greater than 3 x upper limit of normal
Hematocrit < 30% or >48%
Subject is not able to eat 3 frozen study meals per day for 6 months
Subject is unwilling to stop current nutritional supplements
Progressive intensive resistance training within 12 weeks of screening
Non-compliant with run-in diet and/or supplement