The Effect of Pomegranate Juice (PJ) on Oxidative Stress Biomarkers During Treatment With IV Iron During One Dialysis Session

February 7, 2016 updated by: shifra sela, Western Galilee Hospital-Nahariya

The Effect of Pomegranate Juice on Oxidative Stress Biomarkers During Treatment With IV Iron During One Dialysis Session

Atherosclerosis and its related cardiovascular morbidity and mortality, underlie many chronic diseases. Most atherosclerotic patients have multiple cardiovascular risk factors, which potentiate each other, causing a huge burden on health systems. In order to improve the understanding and treatment options of atherosclerosis, it is necessary to identify common basic pathways in its pathogenesis. Oxidative Stress (OS) has a major role in the pathogenesis of atherosclerosis; however, good biomarkers to determine OS are still missing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease (CVD) is a major cause of mortality and morbidity in industrialized countries. CVD associated with atherosclerosis is the major cause of death in patients treated with hemodialysis (HD) in addition to the high morbidity and mortality due to infections. Beside the invaluable goal of improving patients' quality of life, the reduction of the high prevalence of CVD leads to a significant financial consequences by lowering the financial burden on health systems.

Recently, the investigators have reported that half a cup of pomegranate juice (PJ), exceptional for its highest levels of antioxidants, administered 3 times a week for one year at the beginning of each dialysis, had many beneficial effects. The PJ led to a significant reduction of the atherosclerotic process and the rate of hospitalization due to infections: It lowered traditional CV risk factors such as high blood pressure and lipids (triglycerides levels). It improved various systemic non-traditional cardiovascular risk factors such as neutrophil priming, oxidation adducts and pro-inflammatory factors (IL-6, TNFα). Neutrophil priming was previously reported by us as a unique non-traditional CV risk factor involved in different clinical states associated with atherosclerosis. Moreover, the investigators have shown that primed neutrophils separated from HD patients cause endothelial injury that may lead to atherosclerosis and CVD.

The PJ is, thus, effective, vital and important. Yet the PJ in its natural liquid state has an astringent taste and raises doubts and uncertainties with regards to its non-standardized commercial preparation, of undefined composition and shelf life.

The investigators propose to examine PJ or pomegranate extracts containing similar concentrations of total polyphenols as in the investigators previous study in the Turkish juice (ref #2 below), in order to make it more standardized as a dietary supplement to hemodialysis patients.

The investigators plan in this protocol to study the effects of a chosen pomegranate extracts or juice from Primor, in a clinical study in HD patients. The study will be performed in one dialysis session, with and without IV iron and with and without pomegranate juice (4-arms, same patient). Each dialysis session activates neutrophils and induces oxidative stress and inflammation. Therefore, in this clinical study the investigators will assay the beneficial effects of the PJ on oxidative stress and inflammation induced by one dialysis session exacerbated by IV iron.

Each patient will be treated the same day of the week, 4 times, altogether one month per patient.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Nahariya, Israel, 22100
        • Western Galilee Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients on hemodialysis

Exclusion Criteria:

  • patients with infections or cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV iron + PJ
Each patient will serve as a self control
Dietary supplement: PJ
Other Names:
  • pomegranate juice
Drug: IV iron
IV iron is routinely administered to dialysis patients worldwide to correct anemia
Experimental: No IV iron + PJ
Each patient will serve as a self control
Dietary supplement: PJ
Other Names:
  • pomegranate juice
Experimental: IV iron no PJ
Each patient will serve as a self control
Drug: IV iron
IV iron is routinely administered to dialysis patients worldwide to correct anemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidation reduction potential
Time Frame: Immediately before and after dialysis, for 4 various protocols
Each patient will serve as a self control. The metric measurements will be expressed as relative to control potential. Redox potential will be measured as oxidation-reduction potential and reported in millivolts.
Immediately before and after dialysis, for 4 various protocols

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Collaborators

Luoxis

Investigators

  • Principal Investigator: Batya Kristal, MD, Western Galilee Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 7, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0122-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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