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

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ClinicalTrials.gov Identifier: NCT02559843
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Dietary Supplement: pomegranate juice Behavioral: lifestyle modification Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Pomegranate Juice Consumption on Glycemic Control, Lipid Profile, Oxidative Stress and Blood Pressure in Patients With Type 2 Diabetes
Study Start Date : November 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. total antioxidant capacity [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. fasting blood glucose [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559843


Locations
Iran, Islamic Republic of
NNFTRI clinic
Tehran, Iran, Islamic Republic of, 19435
Sponsors and Collaborators
National Nutrition and Food Technology Institute

Responsible Party: Dr Azita Hekmatdoost, Faculty member, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02559843     History of Changes
Other Study ID Numbers: 611
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute:
pomegranate
diabetes
oxidative stress

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases