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

Completed · Not applicable

Conditions studied: Chronic Kidney Disease, Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT01324193

Run by

Kenneth Wilund

People needed

33

Starts

2011-01-01

Expected to finish

2013-06-01

Last updated by the study team

2013-12-16

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1) Subjects must be diagnosed with CKD stage 3, 4 or 5 (glomerular filter rate < 59 mL/min).
• 2) Subjects must be ≥ 30 years of age, to increase the probability of having developed significant arterial stiffness.
• 3) Subjects must be willing to be randomized to the control or intervention groups. The health history questionnaire and PAR-Q will be used to determined eligibility.
• Subjects must complete a medical history and a nephrologist must sign off on a medical clearance for the subject before they can begin the study.

You may not qualify if…

• 1) Subjects < 30 years of age.
• 2) Subjects who are not willing to be randomized to one of the two groups.

Where it is running

• Champaign-Urbana Dialysis Center — Champaign, Illinois, United States

Full record on ClinicalTrials.gov

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