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

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559843
• Other study ID #: 611
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2015
• Last updated: September 23, 2015
• Start date: November 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2015
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: IRAN: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Dietary Supplement:
• pomegranate juice

Behavioral:
• lifestyle modification

Locations

Country	Name	City	State
Iran, Islamic Republic of	NNFTRI clinic	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total antioxidant capacity		6 weeks	No
Secondary	fasting blood glucose		6 weeks	No