Safety and tolerance of medical nutritional products as sole sources of nutrition in people on hemodialysis.

OBJECTIVE: Establish and compare the safety and tolerance of three medical nutritional products when used as sole sources of nutrition in stable hemodialysis patients. DESIGN: Prospectively randomized, controlled, single blind, parallel design. SETTING: Three outpatient hemodialysis clinics. PARTICIPANTS: Seventy-nine normally nourished, stable, anuric, adequately dialyzed, adult outpatients with end-stage renal disease (ESRD) and requiring thrice weekly hemodialysis. INTERVENTION: A 3-week trial was conducted. During the first week, baseline medical history and physical examination, gastrointestinal symptom, urea kinetic, bowel habit, and biochemical data were collected while participants ingested their usual diet. During the last 2 weeks, the same data were collected while participants orally ingested 35 kcal/kg actual weight/d of one of three medical nutritional products as a sole source of nutrition. Products were a standard medical nutritional (EN-9527) and two renal nutritionals (EN-9528 and EN-9529). The latter product was a reformulation of EN-9528 and contained added beta-carotene and fructooligosaccharides. MAIN OUTCOME MEASURES: Gastrointestinal symptoms, bowel habits (stool frequency and consistency), routine blood chemistries, urea kinetics, and normalized protein catabolic rate (nPCR) RESULTS: All three groups achieved a mean energy and protein intake of approximately 35 kcal/kg/d and 1.25 g protein/kg/d during the last 10 days of the sole source feeding period. Adherence with the formula ingestion targets was assessed using both a patient-completed product consumption log and nPCR. By intent to treat analysis, there were no changes in number or severity of gastrointestinal symptoms, stool frequency or stool consistency, or urea kinetics between the baseline week and during product consumption. In comparison to the standard formulation, the disease-specific formulations resulted in improved serum phosphorus and calcium-phosphorus product. Patients receiving the fructooligosaccharide-containing product (EN-9529), by Chi-squared analysis, had less constipation than for the comparable product without oligosaccharides (EN-9528) or the standard medical nutritional (EN-9527). CONCLUSION: Use of enteral nutritionals as a sole source of nutrition is both possible and well tolerated in hemodialyzed patients. Selection of a disease-specific formulation offered advantages over a standard formulation in the management of biochemical complications of renal disease when the products were used as a sole source of nutrition.