Trial record 6 of 72 for:    611

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT02559843
First received: September 15, 2015
Last updated: September 23, 2015
Last verified: September 2015
  Purpose
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 Intervention Phase
Diabetes Type 2
Dietary Supplement: pomegranate juice
Behavioral: lifestyle modification
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Nutrition and Food Technology Institute:

Primary Outcome Measures:
  • total antioxidant capacity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting blood glucose [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2014
Study Completion Date: February 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pomegranate juice
200 ml pomegranate juice + lifestyle modification
Dietary Supplement: pomegranate juice
Active Comparator: control
lifestyle modification including dietary recommendations
Behavioral: lifestyle modification

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02559843

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

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 
Study First Received: September 15, 2015
Last Updated: September 23, 2015
Health Authority: IRAN: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on August 25, 2016