Skip to content

Pomegranate and Hemodialysis Pilot Trial

A Pilot Trial Assessing the Effect of Pomegranate Juice and Extract on Biomarkers of Oxidative Stress, Systemic Inflammation, and Monocyte Function in Hemodialysis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01562340
Acronym
POM Pilot
Enrollment
24
Registered
2012-03-23
Start date
2012-03-31
Completion date
2012-12-31
Last updated
2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, End Stage Renal Disease, Inflammation

Keywords

Hemodialysis, End stage renal disease, Oxidative stress, Inflammation, Endothelial dysfunction, Cardiovascular disease, Antioxidants, Flavonoids

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.

Interventions

OTHERPomegranate 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.

OTHERPomegranate 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.

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Markers of oxidative stress12 weeksOxidative stress: F2-isoprostanes
Markers of inflammation12 weeksInflammation: C-reactive protein, Interleukin-6, and white blood cell count
Markers of endothelial function12 weeksEndothelial function: Monocyte functional assays (cytokines)

Secondary

MeasureTime frameDescription
Number of subjects with adverse events and type of event12 weeksAdverse reactions to pomegranate juice Adverse reactions to pomegranate fruit extract

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026