Nutritional treatment for acquired immunodeficiency virus infection using an enterotropic peptide-based formula enriched with n-3 fatty acids: a randomized prospective trial

Objective: Dietary counseling and intervention based on application of conv entional criteria have been ineffective in preventing the progressive weigh t loss associated with HIV infection. The aim of the study was to compare t he progression of clinical and nutritional indicators during nutritional su pplementation with or without an enterotropic peptide-based formula enriche d with n-3 fatty acids. Design: Randomized trial. Setting: Tertiary care. Subjects: Ninety-one patients were screened for the study. Twenty-three did not meet the inclusion criteria, therefore 74 patients were randomized. Of these, 38 were randomized to group I (standard formula) and 36 were random ized to group II supplementation (enterotropic peptide-based formula enrich ed with n-3 fatty acids). Interventions: Group I received standard enteral formula and group II recei ved a enterotropic peptide-based enteral formula. The volume was the same ( 3 cans/day, 236 ml per can). In both groups enteral supplementation were re commended in conjunction with a registered dietitian under a dietary counse ling program based on standard nutrition principles. Patients received a pr ospective serial assessment of nutrition status, nutritional intake with 24 h written food records, GI symptoms, immune function, anthropometric statu s and intercurrent health events including infections and hospitalization. These determinations were performed at baseline and at 3 months. Results: Treatment with both supplements resulted in a significant and sust ained increase in weight (3.2% in group I and 3.1% in group II); this incre ase was mostly due to fat mass (12.8% in group I) and (7.5% in group II). T otal body water and flit free-mass remained unchanged. CD4 counts remained stable in group I, while a significant increase was detected in group II (5 76 +/- 403 vs 642 +/- 394 cells/mm(3); P < 0.05). After the 3 month period CD4 counts remained higher in group II. Hospitalization events (infections) were also followed during the 3 month period. Group II had fewer hospitali zations than group I, but no statistical differences were found. Conclusions: Oral nutritional supplements for a 3 month period were well to lerated and resulted in body weight gain in HIV-infected patients. Suppleme nt-enriched formula, with peptides and n-3 fatty acids, increased CD4 count .