NCT01275365

Optimizing Protein Intake in Older Americans With Mobility Limitations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mobility Limitation

Interventions

Type	Name	Description
DRUG	Testosterone enanthate	Testosterone enanthate 100 mg intramuscularly weekly
DRUG	Testosterone enanthate	Testosterone enanthate 100 mg intramuscularly weekly

Timeline

• Start date: 2011-05-01
• Primary completion: 2017-01-19
• Completion: 2017-01-19
• First posted: 2011-01-12
• Last updated: 2021-07-29
• Results posted: 2018-02-19

Locations

1 site across 1 country: United States