NCT00117000

The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: University of Adelaide · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine what effect treatment for one year with testosterone and a nutritional supplement, alone and combined, has on the adverse effects of under-nutrition in community-dwelling older men and women.

Detailed description

We hypothesize that oral androgen therapy and nutritional supplementation will have additive beneficial effects in older malnourished individuals living in the community; there will be a reduction in hospitalizations, falls and weight loss in association with improvements in functional measures and increases in lean body mass. The present study is designed to examine the effect of 12 months oral nutrition supplementation and androgen therapy, alone and combined, on (i) frequency and length of hospitalisations; (ii) functional status; (iii) body composition and weight; (iv) living arrangements; (v) death rate, in community dwelling under-nourished men and women, 65 years and older.

Conditions

• Malnutrition
• Aging

Interventions

Type	Name	Description
DRUG	testosterone undecanoate

Timeline

• Start date: 2003-07-01
• Completion: 2007-02-01
• First posted: 2005-07-01
• Last updated: 2006-09-11

Locations

1 site across 1 country: Australia