Rivara Matthew B, Mehrotra Rajnish, Linke Lori, Ruzinski John, Ikizler T Alp, Himmelfarb Jonathan
Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington; Kidney Research Institute, Seattle, Washington.
Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington; Kidney Research Institute, Seattle, Washington.
J Ren Nutr. 2015 Jan;25(1):40-9. doi: 10.1053/j.jrn.2014.07.006. Epub 2014 Sep 11.
Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure.
Prospective, randomized, crossover, pilot clinical trial (NCT01562340).
The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area.
Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period.
Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily.
The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure.
Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production.
Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress nor affect predialysis blood pressure.
氧化应激和全身炎症在维持性血液透析（MHD）患者中非常普遍，且与心血管疾病风险增加有关。本研究旨在探讨短期补充石榴汁和提取物对MHD患者是否安全且耐受性良好。次要目的是评估石榴补充剂对氧化应激、全身炎症、单核细胞功能和血压的影响。
前瞻性、随机、交叉、试点临床试验（NCT01562340）。
该研究于2012年3月至10月在西雅图大都市地区的门诊透析设施中进行。
24例接受MHD的患者（男性占64%；平均年龄61±14岁）被随机分配在为期4周的干预期内接受石榴汁或提取物。经过洗脱期后，所有患者在第二个为期4周的干预期内接受另一种治疗。
分配接受石榴汁的患者在每次透析前饮用100毫升果汁。分配接受石榴提取物的患者每天服用1050毫克提取物。
主要观察指标是石榴汁和提取物的安全性和耐受性。评估的其他次要结果包括血脂、炎症实验室生物标志物（C反应蛋白和白细胞介素6）和氧化应激（血浆F2异前列腺素和异呋喃）、单核细胞细胞因子产生以及透析前血压。
石榴汁和提取物对研究参与者均安全且耐受性良好。在研究期间，两种治疗对血脂谱、血浆C反应蛋白、白细胞介素6、F2异前列腺素或异呋喃浓度、透析前收缩压或舒张压均无显著影响，也未改变单核细胞细胞因子产生水平。
石榴汁和提取物对MHD患者均安全且耐受性良好，但不影响炎症或氧化应激标志物，也不影响透析前血压。
