Pomegranate Juice and Metabolic Syndrome

November 19, 2014 updated by: Urmia University of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome in shabestar.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • liver cirrhosis,
  • chronic pancreatitis,
  • gastrointestinal or connective diseases,
  • kidney stones, or
  • renal failure,
  • alcohol Consumption,
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pomegranate juice
pomegranate juice: 500 ml
Other: pomegranate juice
Randomized clinical trial or RCT
Other: placebo
Randomized clinical trial or RCT
Placebo Comparator: placebo
sugar + aroma+ color: 500ml
Other: pomegranate juice
Randomized clinical trial or RCT
Other: placebo
Randomized clinical trial or RCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in values of metabolic syndrome components at 1 week
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Insulin resistance via HOMA-IR
1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urmia University of Medical Sciences

Investigators

  • Study Director: mohammad alizadeh, Urmia University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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