Effects of Pomegranate Juice on Oxidative Stress in Patients With type2 Diabetes

September 23, 2015 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Effects of Pomegranate Juice Consumption on Glycemic Control, Lipid Profile, Oxidative Stress and Blood Pressure in Patients With Type 2 Diabetes

Introduction: Diabetes mellitus a chronic diseases, is the most common and important metabolic disease in human. Increased free radicals production due to hyperglycemia produces oxidative stress which worsens the disease and its complications. Pomegranate juice has antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure and oxidative stress in patients with type 2 diabetes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

38 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 40-65 years
  • Body Mass Index 18.5-30
  • Fasting blood glucose ≥ 126 mg/dl

Exclusion Criteria:

  • Smoking
  • insulin for blood glucose control
  • taking estrogen or progesterone (if female)
  • Taking antioxidant supplements
  • suffering from any other chronic diseases
  • Participants are also excluded if they missed more than 10% of their pomegranate juice packs

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pomegranate juice
200 ml pomegranate juice + lifestyle modification
Dietary supplement: pomegranate juice
Active Comparator: control
lifestyle modification including dietary recommendations
Behavioral: lifestyle modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total antioxidant capacity
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
fasting blood glucose
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

National Nutrition and Food Technology Institute

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

November 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 611

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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