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 conventional criteria have been ineffective in preventing the progressive weight loss associated with HIV infection. The aim of the study was to compare the progression of clinical and nutritional indicators during nutritional supplementation with or without an enterotropic peptide-based formula enriched 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 randomized to group II supplementation (enterotropic peptide-based formula enriched with n-3 fatty acids). Interventions: Group I received standard enteral formula and group II received a enterotropic peptide-based enteral formula. The volume was the same (3 cans/day, 236 ml per can). In both groups enteral supplementation were recommended in conjunction with a registered dietitian under a dietary counseling program based on standard nutrition principles. Patients received a prospective serial assessment of nutrition status, nutritional intake with 24 h written food records, GI symptoms, immune function, anthropometric status 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 sustained increase in weight (3.2% in group I and 3.1% in group II); this increase was mostly due to fat mass (12.8% in group I) and (7.5% in group II). Total body water and flit free-mass remained unchanged. CD4 counts remained stable in group I, while a significant increase was detected in group II (576 +/- 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 hospitalizations than group I, but no statistical differences were found. Conclusions: Oral nutritional supplements for a 3 month period were well tolerated and resulted in body weight gain in HIV-infected patients. Supplement-enriched formula, with peptides and n-3 fatty acids, increased CD4 count.