End-stage renal disease is the last stage of chronic kidney disease, when the kidneys function at only 10 percent to 15 percent of their normal capacity. At this stage, kidneys cannot effectively remove waste or excess fluid from the blood system, and dialysis or a transplant is necessary to live.
A team of researchers led by Pramod Khosla, Ph.D., Wayne State University associate professor of Nutrition and Food Science, and including James Sondheimer, M.D., WSU associate professor Internal Medicine, will study the effects of a daily supplement of a Tocotrienol-rich fraction from palm oil to determine whether it improves dyslipidemia, a disorder of lipoprotein metabolism that may be manifested by a decrease in the "good" high-density lipoprotein, or HDL, cholesterol in patients with end-stage renal disease who are on hemodialysis. Tocotrienols are a form of Vitamin E and have been shown in recent years to have diverse health effects. In addition, the team will explore the impact on symptoms such as inflammation and symptoms related to Restless Leg Syndrome in the same cohort of patients.
Dr. Khosla believes that the supplement will also act as an anti-inflammatory and antioxidant nutrient, leading to improved nutritional status, lipid profiles, and inflammatory and oxidative stress markers in the kidney patients.
The three-year study, funded by a $2.4 million grant from the Malaysian Palm Oil Board, a premier government agency of Malaysia, will take place in multiple dialysis centers in the United States and Malaysia. The cross-collaboration will allow the investigators to evaluate differences in dietary patterns of 800 dialysis patients in the two countries. With the patient pool in Michigan predominantly African-Americans and Caucasians, and the Malaysian cohort comprised of three distinct ethnicities - Malays, Chinese and Indians - the investigators hope to shed light on possible genetic and metabolic differences in the dialysis populations.
Additionally, because a significant proportion of dialysis patients suffer from Restless Legs Syndrome -- an unpleasant tingling or cramping sensation that impacts the quality of life -- the investigators hope to shed some light on the underlying causes of the condition.
"End-stage renal disease patients undergoing chronic hemodialysis experience a higher risk of complications such as cardiovascular disease, dyslipidemia, Restless Leg Syndrome, insomnia and other health issues," Dr. Khosla said. "In this study, we hope to see significant improvements in various biomarkers that should help decrease some of these complications."
"Dialysis corrects many, but not all, of the symptoms and biochemical abnormalities that occur in kidney failure," said Dr. Sondheimer, chief of the Division of Nephrology and Hypertension at WSU. "We hope to gain a better understanding of how tocotrienols, as substances with antioxidant and anti-inflammatory effects, affect clinical outcomes, as well as metabolic parameters."
Collaborators who will be responsible for patient care include Smiti Gupta, Ph.D., WSU associate professor of Nutrition and Food Science, and Dr. Sondheimer, Boniface Tubie (Great Lakes Dialysis) and Lalathaksha Kumbar (Henry Ford Health System). In addition, registered dietitians, nurses and technical personnel at each of the dialysis units will assist over the course of the study.