Pomegranate and Hemodialysis Pilot Trial (POM Pilot)
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|ClinicalTrials.gov Identifier: NCT01562340|
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : May 28, 2015
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|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%
- Markers of oxidative stress [ Time Frame: 12 weeks ]Oxidative stress: F2-isoprostanes
- Markers of inflammation [ Time Frame: 12 weeks ]Inflammation: C-reactive protein, Interleukin-6, and white blood cell count
- Markers of endothelial function [ Time Frame: 12 weeks ]Endothelial function: Monocyte functional assays (cytokines)
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01562340
|United States, Washington|
|Northwest Kidney Centers|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||Jonathan Himmelfarb, MD||University of Washington|