Aging, Malnutrition
Conditions
Keywords
testosterone, food, formulated, malnutrition, undernutrition, aging, aged, aged, 80 and over, frail elderly
Brief 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.
Interventions
DRUGtestosterone undecanoate
Sponsors
Organon
University of Adelaide
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged 65 years or older who are under-nourished, as defined by a Mini Nutritional Assessment (MNA) score \<24 AND 1 or more of the following: \*a body mass index (BMI) of less than 22 kg/m2; \*weight loss of \> 7.5% in the 3 months before enrolling in the study * Living independently in the community (not in a hospital, nursing home or hostel) * Understand and sign informed consent document, able to communicate with the investigator, and understand and comply with the requirements of the study. * Women who are taking oestrogen or other hormone replacement therapy (HRT) may take part (see
Exclusion criteria
for exceptions), as may women who are not taking HRT. If a woman is taking HRT she must have been on a stable dose for at least 3 months before enrolment in the study. If not on HRT, she must not have been taking it for at least 3 months before enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days in hospital | — |
| SF-36 quality of life scores (composite physical component score and composite mental component score). | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of falls | — |
| Body composition | — |
| Mortality | — |
| Functional status (living arrangements, activities of daily living and frailty scale scores) | — |
| Muscle strength | — |
Countries
Australia
Outcome results
None listed