A randomized comparative trial of testosterone and protein supplements for weight loss in HIV+ men |
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| Affiliation: | 1. RAND Corporation, 1700 Main St., MS-26, Santa Monica, CA 90407-2138, USA;2. New York State Psychiatric Institute, College of Physicians & Surgeons, Columbia University, USA;1. Prodi Kebidanan Metro Poltekkes Tanjungkarang, Lampung, Indonesia;2. Lincoln University College, Malaysia;1. Department of Nephrology, University Clinic, Goethe University, Frankfurt (Main), Germany;2. Department of Radiology, Helios St. Elisabeth Clinic Hünfeld, Hünfeld, Germany;3. Department of Diagnostic and Interventional Radiology, University Clinic, Goethe University, Frankfurt (Main), Germany;4. Department of Gastroenterology, University Clinic, Goethe University, Frankfurt (Main), Germany;5. Department of Nutrition and Dietetics, Bürgerhospital, Internal Medicine, Frankfurt (Main), Germany;7. KFH Nierenzentrum, Frankfurt (Main), Germany;11. Clinic of Internal Medicine 2, University Clinic Halle, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany;1. Department of Medical, Surgical, Neurologic, Metabolic and Geriatric Sciences, Second University of Naples, Naples, Italy;2. Department of Internal Medicine, Faculty of Medicine, University of Catania, Catania, Italy;3. Department of Translational Medical Sciences, University of Naples “Federico II”, Naples, Italy;1. Department of Oncology and Palliative Medicine named after Academician I.A. Savitsky, Russian Medical Academy of Continuous Professional Education, Moscow, Russia;2. Department of Oncology, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;3. Head of the Division of Oncology №4, Moscow Clinical Oncology Hospital № 1 of the Moscow Healthcare Department, Moscow, Russia;4. Associate Professor at the Chair of Oncology and Palliative Medicine named after Academician I.A. Savitsky, Russian Medical Academy of Continuous Professional Education, Moscow, Russia;5. Head of the Chair of Oncology, Novokuznetsk State Institute for Continuous Medical Education, Novokuznetsk, Russia;1. Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Denmark;2. Department of Internal Medicine and Geriatrics, St.-Marien-Hospital Borken, Borken, Germany;3. Nutricia Research, Nutricia Advanced Medical Nutrition, The Netherlands;4. Institute for Biomedicine of Aging, University Erlangen-Nürnberg, Germany |
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| 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. |
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