A RANDOMIZED DOUBLE-BLIND CONTROLLED-STUDY OF 6 MONTHS OF ORAL NUTRITIONAL SUPPLEMENTATION WITH ARGININE AND OMEGA-3-FATTY-ACIDS IN HIV-INFECTED PATIENTS

Objective: To evaluate the effects of an oral nutritional supplement e nriched with two potentially immunostimulant compounds (arginine and O mega-3 fatty acids) on the changes in food intake, body composition, i mmune parameters and viraemia in HIV-infected outpatients. Design: Six -month prospective randomized double-blind controlled study. Setting: University hospital outpatient nutrition clinic. Patients: Sixty-four HIV-infected outpatients with CD4 lymphocyte count greater than or equ al to 100 10(6)/l. Intervention: All patients received a daily oral nu tritional supplement (606 kcal supplemented with vitamins, trace eleme nts and minerals). In addition, half of the patients were randomized t o receive 7.4 g arginine plus 1.7 g Omega-3 fatty acids. Main outcome measures: Disease progression measured by AIDS-defining events, CD4 an d CD8 lymphocyte counts, viraemia, tumour necrosis factor soluble rece ptors, nutritional status determined by anthropometric, bioelectrical impedance and dietetic assessment. Results: Fifty-five patients comple ted the protocol. Compliance with and tolerance of oral nutritional su pplement during the 6-month period was excellent. In both groups of pa tients the following were found: total energy intake was transiently i ncreased and then returned to baseline level; nitrogen/energy intake r atio was increased throughout the study; gain of body weight and fat m ass were approximately 2 and 1 kg, respectively, over 6 months, and we re similar in both groups. In addition, CD4 and CD8 lymphocyte counts, viraemia, tumour necrosis factor soluble receptors remained statistic ally unchanged and were similar in both groups. Conclusions: Enrichmen t of an oral nutritive supplement with arginine and Omega-3 fatty acid s did not improve immunological parameters. However, body weight incre ased in both groups.