Phase 3
N=92
Optimizing Protein Intake in Older Americans With Mobility Limitations
Mobility Limitation
Bottom Line
View on ClinicalTrials.gov: NCT01275365 ↗Enrolled (actual)
92
Serious AEs
5.4%
Results posted
Feb 2018
Primary outcome: Primary: Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA) — 0.14; 0.74; 4.43; 4.13 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Testosterone enanthate (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- Male
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA) |
0.14; 0.74; 4.43; 4.13 | — |
| SECONDARY Change of Maximal Voluntary Strength |
134.6; 156.0; 201.8; 191.4; 41.5; 16.6 | — |
| SECONDARY Change of Leg Press Power |
26.9; 96.9; 61.5; 81.7 | — |
| SECONDARY Change of 6-minute Walking Distance |
44.2; 49.9; 38.2; 25.5 | — |
| SECONDARY Change of Stair Climbing Tests |
50.8; 55.4; 53.2; 4.2; 56.8; 83.7 | — |
| SECONDARY Change of 50-meter Loaded Walking Test |
0.15; 0.11; 0.06; 0.08 | — |
| SECONDARY Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36) |
-1.4; -5.5; 2.1; -2.9 | — |
| SECONDARY Change of Psychological Well Being Index (PGWBI) |
-0.56; 1.17; 0.32; 2.68 | — |
| SECONDARY Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale |
0.14; -0.14; -0.53; 1.05 | — |
| SECONDARY Change of Derogatis Affective Balance Scale (DABS) |
0.65; 1.45; -0.50; -3.17; 1.38; 2.10 | — |
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
- 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 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] 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 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
Data sourced from ClinicalTrials.gov (NCT01275365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.