End Stage Renal DiseasePOM PilotNCT01562340
Pomegranate and Hemodialysis Pilot Trial
A study testing Pomegranate juice and Pomegranate fruit extract in people with End Stage Renal Disease and Cardiovascular Disease, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease, Cardiovascular Disease, Inflammation
- What is being tested?
- Pomegranate juice and Pomegranate fruit extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Being tested
- Pomegranate juice, Pomegranate fruit extract
- Keywords
- Hemodialysis, End stage renal disease, Oxidative stress, Inflammation, Endothelial dysfunction, Cardiovascular disease, Antioxidants, Flavonoids
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate juiceOther
Also called Research Juice 100%
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.
Pomegranate fruit extractOther
Also called Clinical Active POMxp
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.
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate fruit extract | Active comparator | Not described Receives: Other: Pomegranate fruit extract |
| Pomegranate juice | Active comparator | Not described Receives: Other: Pomegranate juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of oxidative stress
Oxidative stress: F2-isoprostanes
Measured: 12 weeks
Markers of inflammation
Inflammation: C-reactive protein, Interleukin-6, and white blood cell count
Measured: 12 weeks
Markers of endothelial function
Endothelial function: Monocyte functional assays (cytokines)
Measured: 12 weeks
Secondary outcomes (1)
Number of subjects with adverse events and type of event
Adverse reactions to pomegranate juice
Adverse reactions to pomegranate fruit extract
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Himmelfarb, University of Washington
- Investigators
- Jonathan Himmelfarb, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562340
- Sponsor's protocol ID
- 41986-D
- Acronym
- POM Pilot
- Status last verified
- May 2015
- First submitted
- 21 Mar 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25218876
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01562340
- Acronym / sponsor ID
- POM Pilot / 41986-D
- Keywords
- Hemodialysis, End stage renal disease, Oxidative stress, Inflammation, Endothelial dysfunction, Cardiovascular disease, Antioxidants, Flavonoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate fruit extract | Active comparator | Other: Pomegranate fruit extract |
| Pomegranate juice | Active comparator | Other: Pomegranate juice |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomegranate juiceAlso: Research Juice 100%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. | Other | Pomegranate juice |
| Pomegranate fruit extractAlso: Clinical Active POMxpPomegranate 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. | Other | Pomegranate fruit extract |
Primary outcome
Markers of oxidative stress
Time frame: 12 weeks
Oxidative stress: F2-isoprostanes
Markers of inflammation
Time frame: 12 weeks
Inflammation: C-reactive protein, Interleukin-6, and white blood cell count
Markers of endothelial function
Time frame: 12 weeks
Endothelial function: Monocyte functional assays (cytokines)
1 secondary outcome
Number of subjects with adverse events and type of event
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 25218876Rivara 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.
- Kidney Research Institute at the University of WashingtonLink provided by the sponsor.
- Northwest Kidney CentersLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Himmelfarb, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate juice and Pomegranate fruit extract in people with End Stage Renal Disease and Cardiovascular Disease, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of oxidative stress (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.