An anti-inflammatory and antioxidant nutritional supplement for hypoalbuminemic hemodialysis patients: a pilot/feasibility study.

BACKGROUND: A low serum albumin concentration < 3.8 g/dL, a marker of malnutrition-inflammation complex syndrome, is observed in approximately half of all maintenance hemodialysis (MHD) patients in the United States and is strongly associated with increased mortality. OBJECTIVES: We hypothesized that a novel oral nutritional intervention with anti-inflammatory and antioxidant properties taken during routine dialysis sessions is well tolerated and corrects hypoalbuminemia in MHD patients. DESIGN: Controlled clinical study. SETTING: An outpatient dialysis facility affiliated with a tertiary care community medical center with six equally distributed hemodialysis shifts and 163 MHD patients. PATIENTS: Among all MHD outpatients of three selected HD shifts (n = 81 patients), 21 subjects had a serum albumin level < 3.8 g/dL. One patient who was hospitalized before the intervention was excluded. The other three dialysis shifts, with 82 MHD outpatients including 20 hypoalbuminemic subjects, were observed as concurrent controls. INTERVENTION: The nutritional intervention included one can of Oxepa and one can of Nepro to be taken together orally during each routine hemodialysis session for 4 weeks. Each can contains 237 mL fluid. Oxepa provides 355 calories and 14.8 g protein per can, includes maltodextrin, medium-chain triglycerides, borage oil, and refined and deodorized fish oil, and is designed for critically ill patients with inflammation and oxidative stress. Each can of Oxepa includes 1,020 mg gamma-linolenic acid, 3,100 mg caprylic acid, 1,080 mg eicosapentaenoic acid, 75 mg taurine, 2,840 IU vitamin A activity, 75 IU vitamin E, and 200 mg vitamin C. Nepro provides 475 calories and 16.7 g protein per can; includes high-oleic safflower oil, corn syrup solids, and fructo-oligosaccharides; and is tailored for the nutritional needs of MHD patients. Oxepa and Nepro also contain L-carnitine, 43 mg and 62 mg, respectively. MAIN OUTCOME MEASURES: Serum albumin pretrial and posttrial. RESULTS: Studied outpatients (12 men and 8 women) were aged 60.4 +/- 13.0 (SD) years. Three patients had started MHD treatment between 1.5 and 3 months before the intervention. Nine patients were diabetic. Preintervention serum albumin, 3.44 +/- 0.34 g/dL (mean +/- SD) increased to 3.68 +/- 0.34 g/dL (P = .001) 4 weeks after the start of the intervention. In 16 patients, serum albumin level increased by 0.2 to 1.3 g/dL, whereas in 4 patients the serum albumin level decreased by 0.2 to 0.6 g/dL. Three patients reported diarrhea, and one diabetic patient had increased serum glucose values. No other side effects were noted. In 20 control outpatients not receiving nutritional intervention, serum albumin did not change from 3.46 +/- 0.20 to 3.47 +/- 10.44 g/dL (P = .47). CONCLUSIONS: In hypoalbuminemic MHD patients, a short-term in-center nutritional intervention with one can of Nepro and one can of Oxepa during HD is practical, convenient, well-tolerated, and associated with a significant increase in serum albumin level. Well-designed randomized placebo-controlled clinical trials are needed to verify the safety and effectiveness of this nutritional intervention and its impact on clinical outcome in hypoalbuminemic MHD patients.

The Nutritional and Inflammatory Evaluation in Dialysis patients (NIED) study: overview of the NIED study and the role of dietitians.

The absolute majority of maintenance hemodialysis (MHD) patients die within 5 years of commencing dialysis treatment, mostly because of cardiovascular (CV) disease. The strongest and most common correlates of death in MHD patients are not conventional CV risk factors, but markers of protein-energy malnutrition and inflammation, together also known as malnutrition-inflammation complex syndrome (MICS). Paradoxically, classic risk factors such as obesity and hypercholesterolemia are associated with better survival in MHD patients. It has been hypothesized that this so-called reverse epidemiology is caused by the overwhelming prevalence and dominating effect of MICS in MHD patients. Hence, the key to improving survival and quality of life in MHD patients may be a better understanding of MICS and its interactions with CV disease and outcome. The Nutritional and Inflammatory Evaluation in Dialysis Patients (NIED) study is a longitudinal multicenter cohort study that aims to examine these hypotheses. At any given semiannual round, approximately 360 MHD patients from 8 DaVita dialysis facilities in the Los Angeles area are examined; 900 MHD patients will be cumulatively studied by the end of this 5-year prospective study (October 2001 to September 2006). Repeated measures of markers of nutritional status and inflammation are performed by 10 to 12 dialysis unit dietitians while patients attend their routine HD treatment in their dialysis facilities. All-cause and CV mortality, hospitalization, and quality of life are studied as outcome measures. The collaborating dietitians are the main evaluators and play crucial roles in all aspects of the study. This article reviews the design and infrastructure of the NIED study and reports preliminary findings of the first 12 to 30 months of the study.