Pomegranate Juice and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

The Effect of Pomegranate Juice Intake on Cardiometabolic Factors in Subjects With Metabolic Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298621
• Other study ID #: 1175
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: November 19, 2014
• Start date: January 2013
• Est. completion date: February 2013

Study information

• Verified date: December 2012
• Source: Urmia University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• pomegranate juice
Randomized clinical trial or RCT
• placebo
Randomized clinical trial or RCT

Locations

Country	Name	City	State
Iran, Islamic Republic of	Urmia University of Medical Sciences	Urmia

Sponsors (1)

Lead Sponsor	Collaborator
Urmia University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in values of metabolic syndrome components at 1 week		1 week	No
Secondary	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	1 weeks	No