Pomegranate Juice and Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: pomegranate juice; Other: placebo

• Registration Number: NCT02298621
• Lead Sponsor: Urmia University of Medical Sciences

Brief Summary

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 Timeline

• Status Verified: 2012-12
• Study Start: 2013-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-19
• Last Update Submitted: 2014-11-19
• Study First Posted: 2014-11-24
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pomegranate juice	placebo	pomegranate juice: 500 ml
placebo	placebo	sugar + aroma+ color: 500ml
pomegranate juice	pomegranate juice	pomegranate juice: 500 ml
placebo	pomegranate juice	sugar + aroma+ color: 500ml

Primary Outcome Measures

Name	Time	Method
Change from baseline in values of metabolic syndrome components at 1 week	1 week

Secondary Outcome Measures

Name	Time	Method
Change from baseline in values of insulin resistance (HOMA-IR), total cholesterol, LDL-C, VLDL-C and hs-CRP at 1 week	1 weeks	Insulin resistance via HOMA-IR

Trial Locations

Locations (1)

Urmia University of Medical Sciences; 🇮🇷 Urmia, Iran, Islamic Republic of