The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

Inclusion Criteria:

• Men and women aged 65 years or older who are under-nourished, as defined by a MiniNutritional Assessment (MNA) score <24 AND 1 or more of the following: *a body massindex (BMI) of less than 22 kg/m2; *weight loss of > 7.5% in the 3 months beforeenrolling 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 theinvestigator, and understand and comply with the requirements of the study.

• Women who are taking oestrogen or other hormone replacement therapy (HRT) may takepart (see exclusion criteria for exceptions), as may women who are not taking HRT. Ifa woman is taking HRT she must have been on a stable dose for at least 3 months beforeenrolment in the study. If not on HRT, she must not have been taking it for at least 3months 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 orinvestigator (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 2times the upper limit of normal)

• Nephrotic syndrome; 24h urine protein excretion > 3 grams (if baseline urinalysisreveals > 1+ proteinuria, quantification will be performed) AND/OR calculatedcreatinine clearance (by the equation of Baracskay and Jarjoura for ambulatory elderlysubjects Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age) < 30 ml/min)AND/OR serum creatinine concentration > 0.2mmol/l.

• Amputee (body mass index, creatinine clearance and body composition estimationsinaccurate).

• Any disease, which in the opinion of the investigator is likely to lead to deathwithin one year

• Testosterone or other androgen therapy (including DHEA and tibolone) in the fourmonths before starting the study.

• Medication with cyclosporin or barbiturates