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Pomegranate and Hemodialysis Pilot Trial (POM Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562340
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Jonathan Himmelfarb, University of Washington

Brief 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

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Cardiovascular Disease Inflammation Other: Pomegranate juice Other: Pomegranate fruit extract Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Trial Assessing the Effect of Pomegranate Juice and Extract on Biomarkers of Oxidative Stress, Systemic Inflammation, and Monocyte Function in Hemodialysis Patients
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Pomegranate fruit extract Other: Pomegranate fruit extract
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 Name: Clinical Active POMxp

Active Comparator: Pomegranate juice Other: Pomegranate juice
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.
Other Name: Research Juice 100%

Primary Outcome Measures :
  1. Markers of oxidative stress [ Time Frame: 12 weeks ]
    Oxidative stress: F2-isoprostanes

  2. Markers of inflammation [ Time Frame: 12 weeks ]
    Inflammation: C-reactive protein, Interleukin-6, and white blood cell count

  3. Markers of endothelial function [ Time Frame: 12 weeks ]
    Endothelial function: Monocyte functional assays (cytokines)

Secondary Outcome Measures :
  1. Number of subjects with adverse events and type of event [ Time Frame: 12 weeks ]

    Adverse reactions to pomegranate juice

    Adverse reactions to pomegranate fruit extract

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with end-stage renal disease receiving thrice weekly hemodialysis
  • Age > 18 or < 85 years
  • Life expectancy greater than one year
  • Ability to understand and provide informed consent for participation in the study

Exclusion Criteria:

  • History of poor adherence to hemodialysis or medical regimen
  • Prisoners, patients with significant mental illness, and other vulnerable populations
  • AIDS (HIV seropositivity is not an exclusion criteria)
  • Active malignancy excluding basal cell carcinoma of the skin
  • Gastrointestinal dysfunction requiring parenteral nutrition
  • History of functional kidney transplant < 6 months prior to study entry
  • Anticipated live donor kidney transplant
  • Patients taking vitamin E supplements > 60 IU/day, vitamin C > 150 mg/day or other antioxidant or nutritional supplements
  • Incident hemodialysis patients (defined as within 30 days of dialysis initiation)
  • Patients hospitalized for more than 5 days within the past 30 days.
  • Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within three months
  • Pregnancy

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 identifier (NCT number): NCT01562340

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United States, Washington
Northwest Kidney Centers
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
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Principal Investigator: Jonathan Himmelfarb, MD University of Washington
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jonathan Himmelfarb, Professor of Medicine, University of Washington Identifier: NCT01562340    
Other Study ID Numbers: 41986-D
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Jonathan Himmelfarb, University of Washington:
End stage renal disease
Oxidative stress
Endothelial dysfunction
Cardiovascular disease
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency