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A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

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.

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  • Authors+Show Affiliations

    ,

    Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington; Kidney Research Institute, Seattle, Washington. Electronic address: mbr@uw.edu.

    ,

    Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington; Kidney Research Institute, Seattle, Washington.

    ,

    Kidney Research Institute, Seattle, Washington.

    ,

    Kidney Research Institute, Seattle, Washington.

    ,

    Division of Nephrology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; Vanderbilt Center for Kidney Disease, Vanderbilt University Medical Center, Nashville, Tennessee.

    Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington; Kidney Research Institute, Seattle, Washington.

    Source

    MeSH

    Aged
    Beverages
    Biomarkers
    C-Reactive Protein
    Cross-Over Studies
    Dietary Supplements
    F2-Isoprostanes
    Female
    Humans
    Inflammation
    Interleukin-10
    Interleukin-1beta
    Interleukin-6
    Linear Models
    Lipids
    Male
    Middle Aged
    Oxidative Stress
    Pilot Projects
    Plant Preparations
    Prospective Studies
    Punicaceae
    Renal Dialysis
    Sensitivity and Specificity
    Treatment Outcome
    Tumor Necrosis Factor-alpha

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    25218876

    Citation

    Rivara, Matthew B., et al. "A Pilot Randomized Crossover Trial Assessing the Safety and Short-term Effects of Pomegranate Supplementation in Hemodialysis Patients." Journal of Renal Nutrition : the Official Journal of the Council On Renal Nutrition of the National Kidney Foundation, vol. 25, no. 1, 2015, pp. 40-9.
    Rivara MB, Mehrotra R, Linke L, et al. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients. J Ren Nutr. 2015;25(1):40-9.
    Rivara, M. B., Mehrotra, R., Linke, L., Ruzinski, J., Ikizler, T. A., & Himmelfarb, J. (2015). A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients. Journal of Renal Nutrition : the Official Journal of the Council On Renal Nutrition of the National Kidney Foundation, 25(1), pp. 40-9. doi:10.1053/j.jrn.2014.07.006.
    Rivara MB, et al. A Pilot Randomized Crossover Trial Assessing the Safety and Short-term Effects of Pomegranate Supplementation in Hemodialysis Patients. J Ren Nutr. 2015;25(1):40-9. PubMed PMID: 25218876.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients. AU - Rivara,Matthew B, AU - Mehrotra,Rajnish, AU - Linke,Lori, AU - Ruzinski,John, AU - Ikizler,T Alp, AU - Himmelfarb,Jonathan, Y1 - 2014/09/11/ PY - 2014/04/08/received PY - 2014/07/08/revised PY - 2014/07/12/accepted PY - 2014/9/15/entrez PY - 2014/9/15/pubmed PY - 2015/9/17/medline SP - 40 EP - 9 JF - Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation JO - J Ren Nutr VL - 25 IS - 1 N2 - 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. SN - 1532-8503 UR - https://www.unboundmedicine.com/medline/citation/25218876/A_pilot_randomized_crossover_trial_assessing_the_safety_and_short_term_effects_of_pomegranate_supplementation_in_hemodialysis_patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1051-2276(14)00126-5 DB - PRIME DP - Unbound Medicine ER -