Pomegranate and Hemodialysis Pilot Trial (POM Pilot)
Primary Purpose
End Stage Renal Disease, Cardiovascular Disease, Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pomegranate juice
Pomegranate fruit extract
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring Hemodialysis, End stage renal disease, Oxidative stress, Inflammation, Endothelial dysfunction, Cardiovascular disease, Antioxidants, Flavonoids
Eligibility Criteria
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 exclusion criteria)
- Active malignancy excluding basal cell carcinoma of the skin
- Gastrointestinal dysfunction requiring parenteral nutrition
- History of functional kidney transplant < 6 months prior to study entry
- Anticipated live donor kidney transplant
- Patients taking vitamin E supplements > 60 IU/day, vitamin C > 150 mg/day or other antioxidant or nutritional supplements
- Incident hemodialysis patients (defined as within 30 days of dialysis initiation)
- Patients hospitalized for more than 5 days within the past 30 days.
- Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within three months
- Pregnancy
Sites / Locations
- Northwest Kidney Centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pomegranate fruit extract
Pomegranate juice
Arm Description
Outcomes
Primary Outcome Measures
Markers of oxidative stress
Oxidative stress: F2-isoprostanes
Markers of inflammation
Inflammation: C-reactive protein, Interleukin-6, and white blood cell count
Markers of endothelial function
Endothelial function: Monocyte functional assays (cytokines)
Secondary Outcome Measures
Number of subjects with adverse events and type of event
Adverse reactions to pomegranate juice
Adverse reactions to pomegranate fruit extract
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01562340
Brief Title
Pomegranate and Hemodialysis Pilot Trial
Acronym
POM Pilot
Official Title
A Pilot Trial Assessing the Effect of Pomegranate Juice and Extract on Biomarkers of Oxidative Stress, Systemic Inflammation, and Monocyte Function in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Cardiovascular Disease, Inflammation
Keywords
Hemodialysis, End stage renal disease, Oxidative stress, Inflammation, Endothelial dysfunction, Cardiovascular disease, Antioxidants, Flavonoids
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pomegranate fruit extract
Arm Type
Active Comparator
Arm Title
Pomegranate juice
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Pomegranate juice
Other Intervention Name(s)
Research Juice 100%
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pomegranate fruit extract
Other Intervention Name(s)
Clinical Active POMxp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Markers of oxidative stress
Description
Oxidative stress: F2-isoprostanes
Time Frame
12 weeks
Title
Markers of inflammation
Description
Inflammation: C-reactive protein, Interleukin-6, and white blood cell count
Time Frame
12 weeks
Title
Markers of endothelial function
Description
Endothelial function: Monocyte functional assays (cytokines)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events and type of event
Description
Adverse reactions to pomegranate juice
Adverse reactions to pomegranate fruit extract
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 exclusion criteria)
Active malignancy excluding basal cell carcinoma of the skin
Gastrointestinal dysfunction requiring parenteral nutrition
History of functional kidney transplant < 6 months prior to study entry
Anticipated live donor kidney transplant
Patients taking vitamin E supplements > 60 IU/day, vitamin C > 150 mg/day or other antioxidant or nutritional supplements
Incident hemodialysis patients (defined as within 30 days of dialysis initiation)
Patients hospitalized for more than 5 days within the past 30 days.
Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within three months
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Himmelfarb, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Kidney Centers
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25218876
Citation
Rivara MB, Mehrotra R, Linke L, Ruzinski J, Ikizler TA, Himmelfarb J. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients. J Ren Nutr. 2015 Jan;25(1):40-9. doi: 10.1053/j.jrn.2014.07.006. Epub 2014 Sep 11.
Results Reference
derived
Links:
URL
http://kri.washington.edu/
Description
Kidney Research Institute at the University of Washington
URL
http://nwkidney.org
Description
Northwest Kidney Centers
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Pomegranate and Hemodialysis Pilot Trial
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