Pomegranate Juice and Metabolic Syndrome

NCT ID: NCT02298621

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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pomegranate juice

pomegranate juice: 500 ml

Group Type EXPERIMENTAL

pomegranate juice

Intervention Type OTHER

Randomized clinical trial or RCT

placebo

Intervention Type OTHER

Randomized clinical trial or RCT

placebo

sugar + aroma+ color: 500ml

Group Type PLACEBO_COMPARATOR

pomegranate juice

Intervention Type OTHER

Randomized clinical trial or RCT

placebo

Intervention Type OTHER

Randomized clinical trial or RCT

Interventions

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pomegranate juice

Randomized clinical trial or RCT

Intervention Type OTHER

placebo

Randomized clinical trial or RCT

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Urmia University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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mohammad alizadeh

Role: STUDY_DIRECTOR

Urmia University of Medical Sciences

Locations

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Urmia University of Medical Sciences

Urmia, , Iran

Site Status

Countries

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Iran

Other Identifiers

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1175

Identifier Type: -

Identifier Source: org_study_id