Cardiovascular Disease (CVD) Clinical Trial
Official title:
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.
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.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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