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

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
pomegranate juice
lifestyle modification
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2 focused on measuring pomegranate, diabetes, oxidative stress

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NNFTRI clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pomegranate juice

control

Arm Description

200 ml pomegranate juice + lifestyle modification

lifestyle modification including dietary recommendations

Outcomes

Primary Outcome Measures

total antioxidant capacity

Secondary Outcome Measures

fasting blood glucose

Full Information

First Posted
September 15, 2015
Last Updated
September 23, 2015
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02559843
Brief Title
Effects of Pomegranate Juice on Oxidative Stress in Patients With type2 Diabetes
Official Title
Effects of Pomegranate Juice Consumption on Glycemic Control, Lipid Profile, Oxidative Stress and Blood Pressure in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
Keywords
pomegranate, diabetes, oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pomegranate juice
Arm Type
Experimental
Arm Description
200 ml pomegranate juice + lifestyle modification
Arm Title
control
Arm Type
Active Comparator
Arm Description
lifestyle modification including dietary recommendations
Intervention Type
Dietary Supplement
Intervention Name(s)
pomegranate juice
Intervention Type
Behavioral
Intervention Name(s)
lifestyle modification
Primary Outcome Measure Information:
Title
total antioxidant capacity
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
fasting blood glucose
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
NNFTRI clinic
City
Tehran
ZIP/Postal Code
19435
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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