Randomized, controlled trial of caloric supplements in HIV infection

Objective: To compare the efficacy of three nutritional regimens in the prevention of weight loss. Design: A three-arm randomized controlled trial with primary outcome measure percent change in weight over four months. Patients: A total of 536 patients with CD4 count <200 cells/mm³ and stable weight, defined as <5% weight loss as determined by a weight measurement 3 to 6 months before randomization were recruited at fourteen administrative units in the United States, each unit consisting of multiple primary care sites. Intervention: The three arms were 500 kcal daily of caloric supplement with peptides and medium-chain triglycerides plus a multivitamin and mineral supplement, 500 kcal of a caloric supplement with whole protein and long- chain triglycerides plus a multivitamin and mineral supplement, and a multivitamin and mineral supplement only. Results: There were no significant differences among the three regimens in the percent change in weight (p = .74) and body cell mass (p = .63). On average, 65% of the recommended 500 kcal/day of caloric supplements containing peptides with medium-chain triglycerides and 82% of the 500 kcal/day of the caloric supplement containing whole protein and long-chain triglycerides were consumed. Conclusions: Caloric supplements do not promote increases in average weight or body cell mass in weight-stable, HIV-infected adults beyond that offered by a multivitamin and mineral supplement.