Pomegranate and Hemodialysis Pilot Trial

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Cardiovascular Disease; Inflammation
• Interventions: Other: Pomegranate fruit extract; Other: Pomegranate juice

• Registration Number: NCT01562340
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pomegranate fruit extract	Pomegranate fruit extract	-
Pomegranate juice	Pomegranate juice	-

Primary Outcome Measures

Name	Time	Method
Markers of endothelial function	12 weeks	Endothelial function: Monocyte functional assays (cytokines)
Markers of oxidative stress	12 weeks	Oxidative stress: F2-isoprostanes
Markers of inflammation	12 weeks	Inflammation: C-reactive protein, Interleukin-6, and white blood cell count

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events and type of event	12 weeks	Adverse reactions to pomegranate juice; Adverse reactions to pomegranate fruit extract

Trial Locations

Locations (1)

Northwest Kidney Centers; 🇺🇸 Seattle, Washington, United States