Optimizing Protein Intake in Older Americans With Mobility Limitations (OPTIMen)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Shalendar Bhasin, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01275365
First received: January 11, 2011
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Mobility Limitation
Drug: Testosterone enanthate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Protein Intake in Older Americans With Mobility Limitations

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in lean body mass as measured by dual energy X-ray absorptiometry (DXA) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)


Secondary Outcome Measures:
  • Tests of Muscle Performance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities; and (3) Power of hip and knee extension by Bassey's leg rig.

  • Tests of Physical Function and Task-Specific Performance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    (1) 6-min walking distance and speed; (2) Stair-climbing power and speed +/- 20% load carry; and (3) 50-meter timed walk + 20% load carry.

  • Self-reported Physical Function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36).

  • Sense of Well-Being, Fatigue and Affectivity Balance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Psychological Well Being Index, FACIT-1 Fatigue scale, and Derogatis Affective Balance Scale (DABS) respectively.


Estimated Enrollment: 152
Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Placebo/Low Protein
Placebo injections weekly; 0.8 g/kg/day protein
No Intervention: Placebo/High Protein
Placebo injections weekly; 1.3 g/kg/day protein
Testosterone/Low Protein
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Drug: Testosterone enanthate
Testosterone enanthate 100 mg intramuscularly weekly
Testosterone/High Protein
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Drug: Testosterone enanthate
Testosterone enanthate 100 mg intramuscularly weekly

Detailed Description:

The recommended dietary allowance (RDA) for protein, set at 0.8 grams/kg/day for adult men and women, has engendered debate and many experts advocate protein intakes substantially above the RDA to help maintain muscle anabolism in older individuals. It is not known whether increasing protein intake in older Americans, whose current intake is below the RDA, increases skeletal muscle mass, muscle performance and physical function.

Our first aim is to determine whether administration of 1.3 g/kg/day of protein, compared to the RDA (0.8 g/kg/day), will result in greater improvements in lean body mass, maximal voluntary muscle strength and power, and self-reported and performance-based measures of physical function in older men. Our second aim is to determine whether the gains in lean body mass, maximal voluntary strength and self-reported and performance-based measures of physical function during testosterone administration are greater with 1.3 g protein than with the RDA in older men on a eucaloric diet.

We will conduct a randomized, placebo-controlled, double-blind trial using a 2 X 2 factorial design. Community dwelling men, 65 years or older, who have self-reported mobility limitation, a daily protein intake of <0.8 g/kg/day and no contraindications for testosterone therapy, will be randomly assigned to one of four groups: placebo injections plus protein 0.8 g/kg/day; placebo injections plus protein 1.3 g/kg/day; testosterone enanthate 100 mg weekly plus protein 0.8 g/kg/day; testosterone enanthate 100 mg weekly plus protein 1.3 g/kg/day. Treatment duration will be 6 months. The primary outcome is change in lean body mass from baseline to 6 months, measured by dual energy X-ray absorptiometry. Secondary outcomes include change in maximal voluntary strength in leg and chest press exercises, leg power, self-reported (physical function domain of SF-36) and performance-based measures of physical function (6-min walking distance and speed, stair climbing power, and load carrying), fatigue, well-being and affectivity balance. Safety measures include urinary calcium excretion, hematocrit, prostate specific antigen (PSA) and prostate examination.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275365

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Matthew Gregorio    617-525-9199    msgregorio@partners.org   
Contact: Shehzad Basaria, MD    617-525-9144    sbasaria@partners.org   
Principal Investigator: Shalender Bhasin, MD         
Principal Investigator: Caroline Apovian, MD         
Sub-Investigator: Shehzad Basaria, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Shalendar Bhasin, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01275365     History of Changes
Other Study ID Numbers: AG037547
Study First Received: January 11, 2011
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Mobility Limitation
Low Protein Intake
Older Men
Testosterone

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 16, 2014