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

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ClinicalTrials.gov Identifier: NCT02107053
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : February 9, 2016
Sponsor:
Collaborator:
Luoxis
Information provided by (Responsible Party):
shifra sela, Western Galilee Hospital-Nahariya

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease (CVD) Dietary Supplement: PJ Drug: IV iron Not Applicable

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  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of Pomegranate Juice on Oxidative Stress Biomarkers During Treatment With IV Iron During One Dialysis Session
Study Start Date : April 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: IV iron + PJ
Each patient will serve as a self control
Dietary Supplement: PJ
Other Name: 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 Name: 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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients on hemodialysis

Exclusion Criteria:

  • patients with infections or cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107053


Locations
Israel
Western Galilee Hospital
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Luoxis
Investigators
Principal Investigator: Batya Kristal, MD Western Galilee Hospital

Publications:

Responsible Party: shifra sela, Head of Research Labs, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT02107053     History of Changes
Other Study ID Numbers: 0122-13
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Keywords provided by shifra sela, Western Galilee Hospital-Nahariya:
Oxidative stress,
hemodialysis,
pomegranate juice,
dietary supplement
patients

Additional relevant MeSH terms:
Cardiovascular Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs