InflammationNCT01033435
The Influence of Cessation of Pomegranate Juice Intake on Inflammation and Oxidative Stress Markers and Glucose Control in Diabetic and Non Diabetic Chronic Hemodialysis Patients
An observational study of Inflammation and Oxidative Stress, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
The current study will investigate chronic hemodialysis patients who were treated in our unit with pomegranate juice intake for 1 year - compared to a control group. Markers will be taken 3 months after cessation of pomegranate juice intake, for inflammation and oxidative stress and Hb A1c. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Oxidative Stress
- How many people
- 49 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2009to Aug 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic Hemodialysis patients, treated in our unit.
Who may be able to join
- Chronic Hemodialysis patients three months after termination of study which is currently carried out at our unit; which compared patients taking pomegranate juice three times a week for 1 year to a group that received placebo juice.
Who cannot join
- Patients who do not currently participate in above mentioned trial
Trial locations and contacts
1 site in 1 country.
About this study
The current study will investigate chronic hemodialysis patients who were treated in our unit with pomegranate juice intake for 1 year - compared to a control group.
Markers will be taken 3 months after cessation of pomegranate juice intake, for inflammation and oxidative stress and Hb A1c.
- Conditions
- Inflammation, Oxidative Stress
- Being tested
- No intervention
- Keywords
- Inflammation, Oxidative stress, HbA1c, Hemodialysis
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| chronic Hemodialysis patients, treated in our unit. | Not described Receives: Other: No intervention | |
| chronic Hemodialysis patients , No intervention | chronic Hemodialysis patients, treated in our unit. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033435
- Sponsor's protocol ID
- Gron09
- Status last verified
- Aug 2011
- First submitted
- 15 Dec 2009
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cessation of Pomegranate Juice Intake on Inflammation and Oxidative Stress Markers and Glucose Control in Diabetic and Non Diabetic Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01033435
- Acronym / sponsor ID
- Gron09
- Conditions
- Inflammation, Oxidative Stress
- Keywords
- Inflammation, Oxidative stress, HbA1c, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Dec 2009
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Dec 2009 (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.
The current study will investigate chronic hemodialysis patients who were treated in our unit with pomegranate juice intake for 1 year - compared to a control group.
Markers will be taken 3 months after cessation of pomegranate juice intake, for inflammation and oxidative stress and Hb A1c.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic Hemodialysis patients, treated in our unit. | – | Other: No intervention |
| chronic Hemodialysis patients , No intervention | – | –chronic Hemodialysis patients, treated in our unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic Hemodialysis patients, treated in our unit.
Key inclusion criteria (1 listed)
- Chronic Hemodialysis patients three months after termination of study which is currently carried out at our unit; which compared patients taking pomegranate juice three times a week for 1 year to a group that received placebo juice.
Key exclusion criteria (1 listed)
- Patients who do not currently participate in above mentioned trial
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 |
|---|---|---|
| No intervention | Other | chronic Hemodialysis patients, treated in our unit. |
Primary outcome
Not reported in the source record.
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 17 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Oxidative Stress, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 1 inclusion and 1 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 17 Aug 2011. 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 Israel. 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.
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 17 Aug 2011.