This trial is active, not recruiting.

Conditions malnutrition, aging
Treatment testosterone undecanoate
Phase phase 3
Sponsor University of Adelaide
Collaborator Organon
Start date July 2003
End date February 2007
Trial size 200 participants
Trial identifier NCT00117000, 030320


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Days in hospital
time frame:
SF-36 quality of life scores (composite physical component score and composite mental component score).
time frame:

Secondary Outcomes

Body composition
time frame:
Muscle strength
time frame:
Number of falls
time frame:
Functional status (living arrangements, activities of daily living and frailty scale scores)
time frame:
time frame:

Eligibility Criteria

Male or female participants at least 65 years old.

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. Exclusion Criteria: - Dementia as indicated by a Folstein’s Mini Mental State Examination (MMSE) score of < 23 - Elevated haematocrit (HCT) levels (>50%) - Past or present history of prostatic cancer in men (Prostate Specific Antigen (PSA) levels [> age-related normal range and/or irregular prostate on prostate examination]) or breast cancer. - Pre-existing androgenic signs or symptoms in women of concern to either subject or investigator (deep voice, hirsutism, acne, androgenic hair loss). - Depression (Yesavage Geriatric Depression Scale (GDS) Score > 11) - Inability to attend DEXA scan or complete other requirements of the study - Significant cardiac failure (NYHA Class III and above) - Significantly abnormal liver function tests (ALT, GGT, bilirubin or ALP more than 2 times the upper limit of normal) - Nephrotic syndrome; 24h urine protein excretion > 3 grams (if baseline urinalysis reveals > 1+ proteinuria, quantification will be performed) AND/OR calculated creatinine clearance (by the equation of Baracskay and Jarjoura for ambulatory elderly subjects [Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)](63) < 30 ml/min) AND/OR serum creatinine concentration > 0.2mmol/l. - Amputee (body mass index, creatinine clearance and body composition estimations inaccurate). - Any disease, which in the opinion of the investigator is likely to lead to death within one year - Testosterone or other androgen therapy (including DHEA and tibolone) in the four months before starting the study. - Medication with cyclosporin or barbiturates

Additional Information

Official title The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly
Principal investigator Ian M Chapman, MBBS, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by University of Adelaide.