The Effect of Pomegranate Juice (PJ) on Oxidative Stress Biomarkers During Treatment With IV Iron During One Dialysis Session
Condition: Cardiovascular Disease (CVD)
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): PJ; IV iron
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): IV iron is routinely administered to dialysis patients worldwide to correct anemia
Other intervention name(s): pomegranate juice
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Oxidative stress,; hemodialysis,; pomegranate juice,; dietary supplement; patients