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Pomegranate Juice and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
pomegranate juice
placebo
Sponsored by
Urmia University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Urmia University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pomegranate juice

placebo

Arm Description

pomegranate juice: 500 ml

sugar + aroma+ color: 500ml

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2014
Last Updated
November 19, 2014
Sponsor
Urmia University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02298621
Brief Title
Pomegranate Juice and Metabolic Syndrome
Official Title
The Effect of Pomegranate Juice Intake on Cardiometabolic Factors in Subjects With Metabolic Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urmia University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pomegranate juice
Arm Type
Experimental
Arm Description
pomegranate juice: 500 ml
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
sugar + aroma+ color: 500ml
Intervention Type
Other
Intervention Name(s)
pomegranate juice
Intervention Description
Randomized clinical trial or RCT
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Randomized clinical trial or RCT
Primary Outcome Measure Information:
Title
Change from baseline in values of metabolic syndrome components at 1 week
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change from baseline in values of insulin resistance (HOMA-IR), total cholesterol, LDL-C, VLDL-C and hs-CRP at 1 week
Description
Insulin resistance via HOMA-IR
Time Frame
1 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammad alizadeh
Organizational Affiliation
Urmia University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Urmia University of Medical Sciences
City
Urmia
ZIP/Postal Code
+98
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Pomegranate Juice and Metabolic Syndrome

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