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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Wilund, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01324193
First received: March 9, 2011
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Cardiovascular Disease
Dietary Supplement: Pomegranate extracts

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Pomegranate Supplementation on Physical Function and Cardiovascular Disease Risk in Chronic Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by University of Illinois at Urbana-Champaign:

Primary Outcome Measures:
  • Markers of oxidative stress [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Markers of inflammation [ Time Frame: Circulating markers of inflammation will be reduced in POM, compared to CON after 12 months of intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular risk [ Time Frame: Carotid artery stiffness and CIMT will be reduced in POM compared to CON after 12 months. ] [ Designated as safety issue: No ]
  • Muscular performance [ Time Frame: Muscle strength and physical performance will be reduced in CON compared to POM after 12 months ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pre-diaylsis patients
Chronic Kidney Disease patients not receiving dialysis getting pomegrante Supplementation
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.
Dialysis patients
Chronic Kidney Disease patients receiving dialysis getting pomegranate supplementation
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.

Detailed Description:

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.

CKD patients will be recruited under 2 phases: CKD patients not receiving dialysis treatment (pre-dialysis patients) will be recruited in the first phase. This will include patients with CKD stage 3-5 that are not yet on dialysis. In the second phase, only CKD patients on dialysis treatment will be recruited. To address these questions, CKD patients will be randomized to the following groups for 12 months: 1) no POM supplementation/control (CON), and 2) oral supplementation with purified pomegranate extract (POM). Patients in the POM group will ingest a 1000 milligram capsule of POM extract, 7 days per week. Patients in the CON group will receive a placebo capsule using the same protocol.

On three occasions, at baseline, 6, and 12 months, each subject will have blood collected to measure plasma markers of oxidative stress (TBARS, lipid peroxides), blood lipid levels, and glucose and insulin levels. Arterial and cardiac structure and function will be measured by vascular ultrasound and echocardiogram, respectively. A 24-hour dietary recall will be used to assess the intake of nutrients. Leg strength will be measured on a resistance exercise machine. Bone density and body composition will be evaluated using dual energy x-ray absorptiometry (DXA). Pre-dialysis subjects will undergo a maximal exercise test to assess their cardiorespiratory fitness level. In dialysis patients, instead of a maximal exercise test, physical function will be measured by a 6-item functional fitness assessment and a 10-meter walk test.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1) Subjects < 30 years of age.
  • 2) Subjects who are not willing to be randomized to one of the two groups.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324193

Locations
United States, Illinois
Champaign-Urbana Dialysis Center
Champaign, Illinois, United States, 61820
Sponsors and Collaborators
Kenneth Wilund
Investigators
Principal Investigator: Kenneth Wilund, PhD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Kenneth Wilund, Prinicpal Responsible Investigator, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01324193     History of Changes
Other Study ID Numbers: 10041
Study First Received: March 9, 2011
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 31, 2014