Chronic Kidney DiseaseNCT01324193
Pomegranate Supplementation on Physical Function and Cardiovascular Disease Risk in CKD Patients
A study testing Pomegranate extracts in people with Chronic Kidney Disease and Cardiovascular Disease, run by Kenneth Wilund at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Kidney Disease, Cardiovascular Disease
- What is being tested?
- Pomegranate extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2013
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) Subjects < 30 years of age.
- 2) Subjects who are not willing to be randomized to one of the two groups.
Trial locations and contacts
1 site in 1 country.
United States1 site
Champaign-Urbana Dialysis Center
Champaign, Illinois, 61820
About this study
Official title: Effects of Pomegranate Supplementation on Physical Function and Cardiovascular Disease Risk in Chronic Kidney Disease Patients
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Cardiovascular Disease
- Being tested
- Pomegranate extracts
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate extractsDietary supplement
a 1000mg capsule of a purified pomegranate polyphenol supplement (POMx™, POM Wonderful, Inc. Los Angeles, CA)7 days a week for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Pre-diaylsis patients | Other | Chronic Kidney Disease patients not receiving dialysis getting pomegrante Supplementation Receives: Dietary Supplement: Pomegranate extracts |
| Dialysis patients | Other | Chronic Kidney Disease patients receiving dialysis getting pomegranate supplementation Receives: Dietary Supplement: Pomegranate extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of oxidative stress
Measured: 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
Measured: Circulating markers of inflammation will be reduced in POM, compared to CON after 12 months of intervention.
Secondary outcomes (2)
Cardiovascular risk
Measured: Carotid artery stiffness and CIMT will be reduced in POM compared to CON after 12 months.
Muscular performance
Measured: Muscle strength and physical performance will be reduced in CON compared to POM after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Wilund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth Wilund, University of Illinois at Urbana-Champaign
- Investigators
- Kenneth Wilund, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324193
- Sponsor's protocol ID
- 10041
- Status last verified
- Dec 2013
- First submitted
- 9 Mar 2011
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pomegranate Supplementation on Physical Function and Cardiovascular Disease Risk in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT01324193
- Acronym / sponsor ID
- 10041
- Conditions
- Chronic Kidney Disease, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Kenneth WilundUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Mar 2011 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-diaylsis patients | Other | Dietary Supplement: Pomegranate extractsChronic Kidney Disease patients not receiving dialysis getting pomegrante Supplementation |
| Dialysis patients | Other | Dietary Supplement: Pomegranate extractsChronic Kidney Disease patients receiving dialysis getting pomegranate supplementation |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 1) Subjects < 30 years of age.
- 2) Subjects who are not willing to be randomized to one of the two groups.
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 extractsa 1000mg capsule of a purified pomegranate polyphenol supplement (POMx™, POM Wonderful, Inc. Los Angeles, CA)7 days a week for 12 months. | Dietary supplement | Dialysis patients, Pre-diaylsis patients |
Primary outcome
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.
Markers of inflammation
Time frame: Circulating markers of inflammation will be reduced in POM, compared to CON after 12 months of intervention.
2 secondary outcomes
Cardiovascular risk
Time frame: Carotid artery stiffness and CIMT will be reduced in POM compared to CON after 12 months.
Muscular performance
Time frame: Muscle strength and physical performance will be reduced in CON compared to POM after 12 months
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 16 Dec 2013.
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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.
Kenneth Wilund, PhD principal investigator
University of Illinois Chicago
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 extracts in people with Chronic Kidney Disease and Cardiovascular Disease, run by Kenneth Wilund 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 2 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 16 Dec 2013. 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: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2013.