Pomegranate and Hemodialysis Pilot Trial

NCT ID: NCT01562340

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

End Stage Renal Disease; Cardiovascular Disease; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pomegranate fruit extract

Group Type: ACTIVE_COMPARATOR

Pomegranate fruit extract

Intervention Type: OTHER

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.

Pomegranate juice

Group Type: ACTIVE_COMPARATOR

Pomegranate juice

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Research Juice 100%; Clinical Active POMxp

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Himmelfarb

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Himmelfarb, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Northwest Kidney Centers

Seattle, Washington, United States

Countries

United States

References

Rivara MB, Mehrotra R, Linke L, Ruzinski J, Ikizler TA, Himmelfarb J. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients. J Ren Nutr. 2015 Jan;25(1):40-9. doi: 10.1053/j.jrn.2014.07.006. Epub 2014 Sep 11.

Reference Type: DERIVED

PMID: 25218876 (View on PubMed)

Related Links

http://kri.washington.edu/

Kidney Research Institute at the University of Washington

http://nwkidney.org

Northwest Kidney Centers

Other Identifiers

41986-D

Identifier Type: -

Identifier Source: org_study_id