NCT01275365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

5.7 years

First QC Date

January 11, 2011

Results QC Date

January 19, 2018

Last Update Submit

July 27, 2021

Conditions

Mobility Limitation

Keywords

Mobility LimitationLow Protein IntakeOlder MenTestosterone

Outcome Measures

Primary Outcomes (1)

  • Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)

    Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)

    6 months from baseline

Secondary Outcomes (9)

  • Change of Maximal Voluntary Strength

    6 months from baseline

  • Change of Leg Press Power

    6 months from baseline

  • Change of 6-minute Walking Distance

    6 months from baseline

  • Change of Stair Climbing Tests

    6 months from baseline

  • Change of 50-meter Loaded Walking Test

    6 months from baseline

  • +4 more secondary outcomes

Study Arms (4)

Placebo/Low Protein

NO INTERVENTION

Placebo injections weekly; 0.8 g/kg/day protein

Placebo/High Protein

NO INTERVENTION

Placebo injections weekly; 1.3 g/kg/day protein

Testosterone/Low Protein

OTHER

Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein

Drug: Testosterone enanthate

Testosterone/High Protein

OTHER

Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein

Drug: Testosterone enanthate

Interventions

Testosterone enanthateDRUG

Testosterone enanthate 100 mg intramuscularly weekly

Testosterone/Low Protein

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

  • Huang G, Pencina K, Li Z, Apovian CM, Travison TG, Storer TW, Gagliano-Juca T, Basaria S, Bhasin S. Effect of Protein Intake on Visceral Abdominal Fat and Metabolic Biomarkers in Older Men With Functional Limitations: Results From a Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 May 22;76(6):1084-1089. doi: 10.1093/gerona/glab007.

    PMID: 33417663DERIVED

  • Krok-Schoen JL, Archdeacon Price A, Luo M, Kelly OJ, Taylor CA. Low Dietary Protein Intakes and Associated Dietary Patterns and Functional Limitations in an Aging Population: A NHANES analysis. J Nutr Health Aging. 2019;23(4):338-347. doi: 10.1007/s12603-019-1174-1.

    PMID: 30932132DERIVED

  • Bhasin S, Apovian CM, Travison TG, Pencina K, Moore LL, Huang G, Campbell WW, Li Z, Howland AS, Chen R, Knapp PE, Singer MR, Shah M, Secinaro K, Eder RV, Hally K, Schram H, Bearup R, Beleva YM, McCarthy AC, Woodbury E, McKinnon J, Fleck G, Storer TW, Basaria S. Effect of Protein Intake on Lean Body Mass in Functionally Limited Older Men: A Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):530-541. doi: 10.1001/jamainternmed.2018.0008.

    PMID: 29532075DERIVED

  • Apovian CM, Singer MR, Campbell WW, Bhasin S, McCarthy AC, Shah M, Basaria S, Moore LL. Development of a Novel Six-Month Nutrition Intervention for a Randomized Trial in Older Men with Mobility Limitations. J Nutr Health Aging. 2017;21(10):1081-1088. doi: 10.1007/s12603-017-0990-4.

    PMID: 29188864DERIVED

MeSH Terms

Conditions

Mobility Limitation

Interventions

testosterone enanthate

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Shalendar Bhasin, MD
Organization
Brigham and Women's Hospital
Sbhasin@partners.org
617-525-9040

Study Officials

  • Shalender Bhasin, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shalendar Bhasin, MD

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 12, 2011

Study Start

May 1, 2011

Primary Completion

January 19, 2017

Study Completion

January 19, 2017

Last Updated

July 29, 2021

Results First Posted

February 19, 2018

Record last verified: 2021-07

Locations

US(1)