A randomized comparative trial of testosterone and protein supplements for weight loss in HIV+ men

Abstract

This report presents findings from a randomized trial that compared the efficacy of 1) 400 mg biweekly IM injections of testosterone plus daily “placebo” standard nutritional supplements (containing 8 g of protein per serving), 2) high protein (37 g per serving) supplements and placebo IM injections, and 3) both testosterone and high protein supplements, in the treatment of HIV-related weight loss. Sixty-five HIV+ men with ≤90% of normative body weight or body cell mass entered the study, of whom 54 (83%) completed the 12-week trial. In an intention to treat analysis, the response rates (defined as an increase of at least 5% in the ratio of body cell mass to height) for testosterone (55%), high protein supplements (62%), and both testosterone and protein supplements (73%) were statistically similar ( p = NS). Amount of change in body weight, body cell mass, fat free mass and body fat from baseline to Week 12 (as measured by bioelectric impedance analysis), all of which were statistically significant within each group, did not differ across the three groups. Among all completers, the average gain in body weight and body cell mass after 12 weeks was 3.5 kgs and 2.0 kgs, respectively; 77% of the increase in body weight was fat free body mass, compared to 23% fat. These data support the efficacy of both testosterone and high protein supplements as independent treatments for HIV-related weight loss, but do not demonstrate a further advantage of combining the treatments.