Chapman I, VisvanathanR, et al, 2009

19144729

Effect of testosterone and a nutritional supplement, alone and in combination, on hospital admissions in undernourished older men and women.

Chapman I, Visvanathan R, Hammond A, Morley J, Field J, Tai K, Belobrajdic D, Chen R, Horowitz M

The American Journal of Clinical Nutrition

2009

89

3

880-9

Randomized Controlled Trial

Some concerns

Undernourished men and women; age >/= 65 years (defined by a Mini Nutritional Assessment (MNA) score of <24 of 30 and BMI <22 or a self-reported weight loss of 7.5% in the 3 mo before enrolling in the study; living independently in the community.

Inability to comply with the protocol; increased risk of cognitive impairment [Folstein’s Mini Mental State Examination score 50%); history of prostate cancer, prostate-specific antigen (PSA) concentrations greater than the age-related normal range, or an irregular prostate on examination; breast cancer; preexisting androgenic signs or symptoms of concern (deep voice, hirsutism, acne, or androgenic hair loss) in women; risk of depression (Yesavage Geriatric Depression Scale score >/=11); cardiac failure corresponding to New York Heart Association class III and above; abnormal liver function tests (alanine aminotransferase, c-glutamyltransferase, bilirubin, or alkaline phosphatase >2 times the upper limit of normal); serum creatinine >0.2 mmol/L; any disease that, in the opinion of the investigator, was likely to lead to death within 1 year; testosterone or other androgen therapy within 4 mo of starting the study.

To determine the effects, particularly on hospital admissions, of a nutritional supplement and testosterone, alone and combined, in undernourished older people.

Not reported

Australia

Industry

Organon Ltd Novartis