Metabolic SyndromeNCT02298621
Pomegranate Juice and Metabolic Syndrome
A study testing pomegranate juice in people with Metabolic Syndrome, run by Urmia University of Medical Sciences at 1 site in Iran.
Trial summary
The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- pomegranate juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Jan 2013to Feb 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presence of ≥3 of the following diagnostic of MetS:
- serum TGs of at least 150 mg/dL,
- waist circumference of more than 102 cm (40 in) in men and more than 88 cm (35 in) in women,
- high-density lipoprotein (HDL) level less than 40 mg/dL in men and less than 50 mg/dL in women,
- blood pressure 135/85 mm Hg or higher, or
- fasting glucose 100 mg/dL or Higher
Who cannot join
- liver cirrhosis,
- chronic pancreatitis,
- gastrointestinal or connective diseases,
- kidney stones, or
- renal failure,
- alcohol Consumption,
Show all 11Show fewer
- having an allergy to pomegranate juice,
- a change in diet,
- the large increase in LDL so that required drug treatment.
- use of statins of fibrates, corticosteroids, nitrates, acetyl-salicylic acid or other anti-platelet drugs, oral hypoglycemic drugs, nonsteroidal anti-inflammatory drugs, or drugs interfering with coagulation;
- pregnancy or lactation in the past 6 mo, supplementation with vitamins or antioxidants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pomegranate Juice Intake on Cardiometabolic Factors in Subjects With Metabolic Syndrome.
The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome.
Read the detailed description
The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome in shabestar.
- Conditions
- Metabolic Syndrome
- Being tested
- pomegranate juice, placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pomegranate juiceOther
Randomized clinical trial or RCT
placeboOther
Randomized clinical trial or RCT
| Study group | Role | What they receive |
|---|---|---|
| pomegranate juice | Experimental | pomegranate juice: 500 ml Receives: Other: pomegranate juice; Other: placebo |
| placebo | Placebo comparator | sugar + aroma+ color: 500ml Receives: Other: pomegranate juice; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in values of metabolic syndrome components at 1 week
Measured: 1 week
Secondary outcomes (1)
Change from baseline in values of insulin resistance (HOMA-IR), total cholesterol, LDL-C, VLDL-C and hs-CRP at 1 week
Insulin resistance via HOMA-IR
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urmia University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohammad alizadeh, Study director, Urmia University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298621
- Sponsor's protocol ID
- 1175
- Status last verified
- Dec 2012
- First submitted
- 5 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pomegranate Juice Intake on Cardiometabolic Factors in Subjects With Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT02298621
- Acronym / sponsor ID
- 1175
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Urmia University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Nov 2014 (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 effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome.
Detailed description
The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome in shabestar.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pomegranate juice | Experimental | Other: pomegranate juice, Other: placebopomegranate juice: 500 ml |
| placebo | Placebo comparator | Other: pomegranate juice, Other: placebosugar + aroma+ color: 500ml |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- presence of ≥3 of the following diagnostic of MetS:
Key exclusion criteria (11 listed)
- liver cirrhosis,
- chronic pancreatitis,
- gastrointestinal or connective diseases,
- kidney stones, or
- renal failure,
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 juiceRandomized clinical trial or RCT | Other | placebo, pomegranate juice |
| placeboRandomized clinical trial or RCT | Other | placebo, pomegranate juice |
Primary outcome
Change from baseline in values of metabolic syndrome components at 1 week
Time frame: 1 week
1 secondary outcome
Change from baseline in values of insulin resistance (HOMA-IR), total cholesterol, LDL-C, VLDL-C and hs-CRP at 1 week
Time frame: 1 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 24 Nov 2014.
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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.
mohammad alizadeh study director
Urmia University of Medical Sciences
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 in people with Metabolic Syndrome, run by Urmia University of Medical Sciences at 1 site in Iran.
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 6 inclusion and 11 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 24 Nov 2014. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in values of metabolic syndrome components at 1 week (time frame: 1 week). 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 24 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.