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Pomegranate and Hemodialysis Pilot Trial (POM Pilot)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jonathan Himmelfarb, University of Washington
ClinicalTrials.gov Identifier:
NCT01562340
First received: March 21, 2012
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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 Intervention
End Stage Renal Disease
Cardiovascular Disease
Inflammation
Other: Pomegranate juice
Other: Pomegranate fruit extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Markers of oxidative stress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Oxidative stress: F2-isoprostanes, polyphenols and lipid soluble antioxidants

  • Markers of inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Inflammation: C-reactive protein, Interleukin-6, and white blood cell count

  • Markers of endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Endothelial function: Monocyte functional assays (cytokines and other proteins), Pulse amplitude tonometry


Secondary Outcome Measures:
  • Number of subjects with adverse events and type of event [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    Advere reactions to pomegranate juice

    Adverse reactions to pomegrantate fruit extract



Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562340

Contacts
Contact: Lori Linke, BA, DTR 206-616-8574 lori.linke@nwkidney.org
Contact: John Kundzins, BS 206-616-8574 info@KRI.washington.edu

Locations
United States, Washington
Northwest Kidney Centers Recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Jonathan Himmelfarb, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Jonathan Himmelfarb, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT01562340     History of Changes
Other Study ID Numbers: 41986-D
Study First Received: March 21, 2012
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Hemodialysis
End stage renal disease
Oxidative stress
Inflammation
Endothelial dysfunction
Cardiovascular disease
Antioxidants
Flavonoids

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014