The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes

December 30, 2013 updated by: Maryam Zare, Ahvaz Jundishapur University of Medical Sciences
The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

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 Contact

Study Locations

  • Iran, Islamic Republic of
    • Khoozestan
      • Ahvaz, Khoozestan, Iran, Islamic Republic of
        • Recruiting
        • Ahvaz Jundishapoor University of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Maryam Zare, MS condidate

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

23 years to 58 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female 25 to 60 years old
  • having type 2 diabetes for at least 6 month

Exclusion Criteria:

  • pregnancy
  • lactation
  • cardiac disease
  • hepatic disease
  • respiratory disease
  • chronic renal diseases
  • acute or chronic inflammation
  • retinopathy
  • intake of antioxidant supplement
  • insulin therapy
  • sensitivity to concentrated pomegranate juice
  • change oral drug for controlling blood glucose

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 50 gr concentrated pomegranate juice
Other: 50 gr concentrated pomegranate juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Triglyceride change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks
Total Cholesterol change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks
HDL- Cholesterol change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks
LDL- Cholesterol change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks
hsCRP change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks
TNF- α change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks
IL-6 change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks
adiponectin change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Blood Sugar change
Time Frame: baseline and after 4 weeks
baseline and after 4 weeks
Blood Pressure change
Time Frame: Baseline and after 4 weeks
Baseline and after 4 weeks
Body Mass Index change
Time Frame: baseline and after 4 weeks
baseline and after 4 weeks

Collaborators and Investigators

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

Sponsor

Ahvaz Jundishapur 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 (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 14, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 30, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRCT2013091614680N1

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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