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Pomegranate Supplementation on Physical Function and Cardiovascular Disease Risk in CKD Patients

NCT01324193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2013-12-16

No results posted yet for this study

Summary

Chronic kidney disease (CKD) patients have very low physical function and high rates of cardiovascular disease (CVD) mortality. The objective of the proposed research is to evaluate the effects of dietary supplementation with a pomegranate extract, that contains high amounts of antioxidants, on physical function and CVD risk. Patients with moderate to severe chronic kidney disease that are NOT yet on dialysis tend to have significantly reduced risk factors for cardiovascular disease (and other disorders) compared to dialysis patients. This includes significantly reduced systemic markers of oxidative stress and inflammation. As a result, therapies designed to reduce the risk of CKD co-morbidities may differ significantly in dialysis and pre-dialysis patients. For example, dialysis patients are recommended to INCREASE their intake of dietary protein, while pre-dialysis patients are recommended to DECREASE their protein intake, due to differences in the pathophysiology of the two conditions. The investigators have decided to recruit pre-dialysis patients in addition to dialysis patients in this study because the investigators believe this will help us determine if the efficacy of pomegranate differs between patients with different stages of CKD.

Conditions

Interventions

DIETARY_SUPPLEMENT

Pomegranate extracts

a 1000mg capsule of a purified pomegranate polyphenol supplement (POMx™, POM Wonderful, Inc. Los Angeles, CA)7 days a week for 12 months.

Sponsors & Collaborators

  • Kenneth Wilund

    lead OTHER

Principal Investigators

  • Kenneth Wilund, PhD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01324193 on ClinicalTrials.gov