Pomegranate and Hemodialysis Pilot Trial
Condition: End Stage Renal Disease; Cardiovascular Disease; Inflammation
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Cardiovascular Diseases; Inflammation
Study type: Interventional

Summary: 
      In this study, the investigators will administer pomegranate juice or fruit extract as a
      targeted antioxidant therapy to hemodialysis patients.

      The investigators will examine whether these pomegranate products will be safe and
      well-tolerated. The investigators will also examine whether these products may lead to
      improvements in blood serum biomarkers of:

        -  oxidative stress status

        -  inflammatory status

        -  endothelial dysfunction
    

Detailed description: 
      There are currently more than 400,000 patients receiving chronic dialysis therapy in the
      United States. Cardiovascular and infectious diseases are the leading causes of death in
      hemodialysis patients, accounting for over 50% of all-cause mortality.

      There is a complex interaction of inflammation, oxidative stress, and endothelial dysfunction
      in contributing to cardiovascular and infectious risk in dialysis patients. Since there is
      much evidence that an increase in oxidative stress contributes to risk of disease in dialysis
      patients, it is logical to hypothesize the antioxidant therapy may be beneficial in reducing
      these risks.

      In addition to vitamins C and E, the most common and active antioxidant compounds that occur
      naturally in foods are flavonoids. Dietary flavonoids are highly bioavailable, and have been
      shown to confer antioxidant protection, inhibit platelet activation, exert vasorelaxant
      effects, and reduce inflammation in human studies. In animal model studies, dietary
      flavonoids have been shown to reduce the development of atherosclerosis. Polyphenols also
      have potent antibacterial, antifungal, and antiviral activities.

      Pomegranate juice is a rich source of potent phenolic antioxidants, which have been
      demonstrated to have anti-atherogenic and vasorelaxant properties. Pomegranate derived
      polyphenols have also been demonstrated to inhibit platelet activation.

      Although available data are limited, several studies suggest that dietary phenols may have
      beneficial effects in patients undergoing dialysis treatment. These include improvements in
      lipoprotein profiles, reductions in circulating inflammatory and oxidative stress biomarkers,
      reductions in infectious complications, and improvements in inflammatory biomarkers. These
      observations, though limited, suggest that polyphenol based supplementation strategies may be
      effective in reducing complications in those undergoing dialysis treatment.

      In this study, the investigators will administer pomegranate juice and/or fruit extract as a
      targeted antioxidant therapy. The investigators will examine whether these pomegranate
      products will be safe and well-tolerated. The investigators will also examine whether these
      products may lead to improvements in biomarkers of oxidative stress status, inflammatory
      status, and endothelial dysfunction in hemodialysis patients.
    

Intervention name(s): Pomegranate juice; Pomegranate fruit extract
Intervention type(s): Other; Other
Intervention description(s): Pomegranate juice (100 mL) 3 times per week (taken prior to hemodialysis session) for 4 weeks. Followed by 4 week wash-out (no intervention), then crossover to Comparator arm.; Pomegranate fruit extract in single capsule (1050 mg) daily by mouth for 4 weeks. Followed by 4 week wash-out (no intervention), then crossover to Comparator arm.
Other intervention name(s): Research Juice 100%; Clinical Active POMxp
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hemodialysis; End stage renal disease; Oxidative stress; Inflammation; Endothelial dysfunction; Cardiovascular disease; Antioxidants; Flavonoids