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

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ClinicalTrials.gov Identifier: NCT01275365
Recruitment Status : Completed
First Posted : January 12, 2011
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Shalendar Bhasin, MD, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Drug: Testosterone enanthate Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Protein Intake in Older Americans With Mobility Limitations
Study Start Date : May 2011
Actual Primary Completion Date : January 19, 2017
Actual Study Completion Date : January 19, 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA) [ Time Frame: 6 months from baseline ]
    Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)


Secondary Outcome Measures :
  1. Change of Maximal Voluntary Strength [ Time Frame: 6 months from baseline ]
    Tests of Muscle Performance: (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.

  2. Change of Leg Press Power [ Time Frame: 6 months from baseline ]
    Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig.

  3. Change of 6-minute Walking Distance [ Time Frame: 6 months from baseline ]
    Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance

  4. Change of Stair Climbing Tests [ Time Frame: 6 months from baseline ]
    Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry.

  5. Change of 50-meter Loaded Walking Test [ Time Frame: 6 months from baseline ]
    Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry.

  6. Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36) [ Time Frame: 6 months from baseline ]
    36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36) contains 10 items with the score range of 0-100. Higher score yields better performance.

  7. Change of Psychological Well Being Index (PGWBI) [ Time Frame: 6 months from baseline ]
    The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The 22 items are grouped in 6 dimensions. A global score is computed as the sum of all items with range of 0-110. A higher score yields better performance.

  8. Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale [ Time Frame: 6 months from baseline ]
    The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.

  9. Change of Derogatis Affective Balance Scale (DABS) [ Time Frame: 6 months from baseline ]
    The Derogatis Affects Balance Scale (DABS) is a multidimensional self-report mood and affects inventory comprised of 40 adjective-items using a 5-point Likert style scale. The DABS global scores consist of the Positive Total score (PTOT), Negative Total score (NTOT), where The Positive Affects Total (PTOT) is defined as the sum of all scores on the four positive affects dimensions of joy, contentment, vigor and affection, ranging 0-80. Similarly, the Negative Affects Total (NTOT) is represented as the sum of scores on the four negative dimensions of anxiety, depression, guilt and hostility, ranging 0-80. The Affects Expressiveness Index (AEI) is defined as the sum total of PTOT and NTOT, ranging 0-160. Higher score yields stronger affective intensity.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275365


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Shalendar Bhasin, MD, Brigham and Women's Hospital:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shalendar Bhasin, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01275365     History of Changes
Other Study ID Numbers: AG037547
First Posted: January 12, 2011    Key Record Dates
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018
Last Verified: January 2018

Keywords provided by Shalendar Bhasin, MD, 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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents