The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
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.
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.
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