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

NCT01324193 | Completed DMC

• 1 other identifier: 10041
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Kidney Disease; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Markers of oxidative stress

  Circulating markers of oxidative stress will be reduced and serum antioxidant activity will be increased in POM, compared to CON after 12 months of intervention.

• Markers of inflammation

  Circulating markers of inflammation will be reduced in POM, compared to CON after 12 months of intervention.

Secondary Outcomes (2)

• Cardiovascular risk

  Carotid artery stiffness and CIMT will be reduced in POM compared to CON after 12 months.

• Muscular performance

  Muscle strength and physical performance will be reduced in CON compared to POM after 12 months

Study Arms (2)

Pre-diaylsis patients

OTHER

Chronic Kidney Disease patients not receiving dialysis getting pomegrante Supplementation

Dietary Supplement: Pomegranate extracts

Dialysis patients

OTHER

Chronic Kidney Disease patients receiving dialysis getting pomegranate supplementation

Dietary Supplement: Pomegranate extracts

Interventions

Pomegranate extracts DIETARY_SUPPLEMENT

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

Dialysis patients; Pre-diaylsis patients

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Subjects must be diagnosed with CKD stage 3, 4 or 5 (glomerular filter rate \< 59 mL/min).
• \) Subjects must be ≥ 30 years of age, to increase the probability of having developed significant arterial stiffness.
• \) 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:

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

Sponsors & Collaborators

• Kenneth Wilund: lead

Study Sites (1)

Champaign-Urbana Dialysis Center

Champaign, Illinois, 61820, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Wilund, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicpal Responsible Investigator

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 28, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

US (1)