Matthew B Rivara1, Rajnish Mehrotra2, Lori Linke3, John Ruzinski3, T Alp Ikizler4, Jonathan Himmelfarb2. 1. Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington; Kidney Research Institute, Seattle, Washington. Electronic address: mbr@uw.edu. 2. Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington; Kidney Research Institute, Seattle, Washington. 3. Kidney Research Institute, Seattle, Washington. 4. Division of Nephrology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; Vanderbilt Center for Kidney Disease, Vanderbilt University Medical Center, Nashville, Tennessee.
Abstract
OBJECTIVE: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. DESIGN: Prospective, randomized, crossover, pilot clinical trial (NCT01562340). SETTING: The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. SUBJECTS: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. INTERVENTION: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: 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 pomegranatejuice 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. DESIGN: Prospective, randomized, crossover, pilot clinical trial (NCT01562340). SETTING: The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. SUBJECTS: Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranatejuice 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. INTERVENTION: Patients assigned to receive pomegranatejuice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. MAIN OUTCOME MEASURES: The main outcome measures were safety and tolerability of pomegranatejuice 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. RESULTS: Both pomegranatejuice 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. CONCLUSIONS: Both pomegranatejuice 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.
Authors: Ana Rodriguez-Mateos; Catarina Rendeiro; Triana Bergillos-Meca; Setareh Tabatabaee; Trevor W George; Christian Heiss; Jeremy Pe Spencer Journal: Am J Clin Nutr Date: 2013-09-04 Impact factor: 7.045
Authors: M Boaz; S Smetana; T Weinstein; Z Matas; U Gafter; A Iaina; A Knecht; Y Weissgarten; D Brunner; M Fainaru; M S Green Journal: Lancet Date: 2000-10-07 Impact factor: 79.321
Authors: Jonathan Himmelfarb; T Alp Ikizler; Charles Ellis; Pingsheng Wu; Ayumi Shintani; Sanjay Dalal; Mark Kaplan; Michel Chonchol; Raymond M Hakim Journal: J Am Soc Nephrol Date: 2013-12-26 Impact factor: 10.121