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Evaluation of high-protein supplementation in weight-stable HIV-positive subjects with a history of weight loss: a randomized, double-blind, multicenter trial^1,2,3

¹ From the Keck School of Medicine, University of Southern California, Los Angeles, CA (FRS); the Department of Biostatistics, Harvard School of Public Health, Boston MA (NR); the University of California, San Francisco and San Francisco General Hospital, San Francisco, CA (KM); the Department of Internal Medicine, Washington University School of Medicine, St Louis, MO (KEY); the Division of Infectious Diseases, Ohio State University, Columbus, OH (SLK); Stanford University, School of Medicine, Stanford, CA (AZ); the Division of AIDS of the National Institute of Allergy and Infectious Diseases, Bethesda, MD (BAS); the Department of Biostatistics, Harvard School of Public Health, Boston, MA, and the Department of Medicine (RZ), Beth Israel Deaconess Medical Center, Harvard Medical School (BB) Boston, MA

Background: HIV patients with wasting are at increased risk of opportunistic complications and fatality.

Objective: We hypothesized that augmenting dietary intake with high-biologic-value protein would enhance weight and lean tissue in weight-stable subjects with a prior unintentional weight loss of >3%.

Design: Fifty-nine subjects with HIV RNA concentrations <5000 copies/mL were randomly assigned to receive a 280-kcal supplement containing 40 g whey protein or a matched isocaloric control supplement without added protein twice daily for 12 wk.

Results: Before the study, intake of total energy and protein exceeded estimated requirements (44.3 ± 12.6 kcal · kg^–1 · d^–1 and 1.69 ± 0.55 g · kg^–1 · d^–1, respectively). Both supplements failed to increase total energy intake because of decreases in self-selected food intake. Changes in weight (0.8 ± 2.4 and 0.7 ± 2.4 kg) and lean body mass (0.3 ± 1.4 and 0.3 ± 1.5 kg) did not differ significantly between the whey protein and control groups, respectively. Waist-to-hip ratio improved more with whey protein (–0.02 ± 0.05) than with the control (0.01 ± 0.03; P = 0.025) at week 6 but not at week 12. Fasting triacylglycerol increased by 39 ± 98 mg/dL with the control supplement and decreased by 16 ± 62 mg/dL with whey protein at week 12 (P = 0.03). CD4 lymphocytes increased by 31 ± 84 cells/mm³ with whey protein and decreased by 5 ± 124 cells/mm³ with the control supplement at 12 wk (P = 0.03). Gastrointestinal symptoms occurred more often with whey protein.

Conclusions: A whey protein supplement did not increase weight or lean body mass in HIV-positive subjects who were eating adequately, but it did increase CD4 cell counts. The control supplement with rapidly assimilable carbohydrate substituted for protein increased cardiovascular disease risk factors. Careful dietary and weight history should be obtained before starting nutritional supplements in subjects with stable weight loss and good viral control.