An Anti-Inflammatory and Antioxidant Nutritional Supplement for Hypoalbuminemic Hemodialysis Patients: A Pilot/Feasibility Study

Kalantar-Zadeh, Kamyar; Braglia, Amy; Chow, Joanne; Kwon, Osun; Kuwae, Noriko; Colman, Sara; Cockram, David B.; Kopple, Joel D.

doi:10.1016/j.jrn.2005.04.004

« Previous Next »Journal of Renal Nutrition
Volume 15, Issue 3 , Pages 318-331, July 2005

An Anti-Inflammatory and Antioxidant Nutritional Supplement for Hypoalbuminemic Hemodialysis Patients: A Pilot/Feasibility Study

Presented in part in the 12^th International Congress on Nutrition and Metabolism in Renal Disease, Abano Terme, Italy, June 19–22, 2004; and in the annual conference of the American Society of Nephrology, St. Louis, MO, October 27–30, 2004.

Kamyar Kalantar-Zadeh, MD, PhD, MPH
- Division of Nephrology and Hypertension, Los Angeles Biomedical Institute at Harbor-UCLA Medical Center, Torrance, CA.
- Harbor-UCLA MFI DaVita Dialysis Center, Torrance, CA.
- Address reprint requests to Kamyar Kalantar-Zadeh, MD, PhD, MPH, Division of Nephrology and Hypertension, Harbor-UCLA Medical Center, Harbor Mailbox 406, 1000 West Carson Street, Torrance, CA 90509-2910.
Amy Braglia, RD
- Harbor-UCLA MFI DaVita Dialysis Center, Torrance, CA.
Joanne Chow, RD
- Harbor-UCLA MFI DaVita Dialysis Center, Torrance, CA.
Osun Kwon, MD, PhD
- Division of Nephrology and Hypertension, Los Angeles Biomedical Institute at Harbor-UCLA Medical Center, Torrance, CA.
- Harbor-UCLA MFI DaVita Dialysis Center, Torrance, CA.
Noriko Kuwae, MD
- Division of Nephrology and Hypertension, Los Angeles Biomedical Institute at Harbor-UCLA Medical Center, Torrance, CA.
- Department of Nephrology, Nakagami Hospital, Okinawa, Japan.
Sara Colman, RD
- DaVita Norwalk Dialysis Center, Norwalk, CA.
David B. Cockram, PhD, RD
- Ross Products Division, Abbott Laboratories, Columbus, OH.
Joel D. Kopple, MD
- Division of Nephrology and Hypertension, Los Angeles Biomedical Institute at Harbor-UCLA Medical Center, Torrance, CA.
- Harbor-UCLA MFI DaVita Dialysis Center, Torrance, CA.
- School of Public Health, University of California, Los Angeles, CA.

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 γ-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.