Clinical trial NCT00117000: The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
Official title: The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Malnutrition
Aging
Keywords: testosterone
food, formulated
malnutrition
undernutrition
aging
aged
aged, 80 and over
frail elderly
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2005-07-01
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Days in hospital
measure: SF-36 quality of life scores (composite physical component score and composite mental component score).
Secondary outcomes:
measure: Body composition
measure: Muscle strength
measure: Number of falls
measure: Functional status (living arrangements, activities of daily living and frailty scale scores)
measure: Mortality
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: University of Adelaide
name: Ian M Chapman, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
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