The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02024516
• Other study ID #: IRCT2013091614680N1
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2013
• Last updated: December 30, 2013
• Start date: January 2013

Study information

• Verified date: December 2013
• Source: Ahvaz Jundishapur University of Medical Sciences
• Contact: Maryam Zare, MS condidate
• Phone: +989132275832
• Email: zare.m[@]ajums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: December 2013
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• male or female 25 to 60 years old

• having type 2 diabetes for at least 6 month

Exclusion Criteria:

• pregnancy

• lactation

• cardiac disease

• hepatic disease

• respiratory disease

• chronic renal diseases

• acute or chronic inflammation

• retinopathy

• intake of antioxidant supplement

• insulin therapy

• sensitivity to concentrated pomegranate juice

• change oral drug for controlling blood glucose

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• 50 gr concentrated pomegranate juice

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ahvaz Jundishapoor University of Medical Sciences	Ahvaz	Khoozestan

Sponsors (1)

Lead Sponsor	Collaborator
Ahvaz Jundishapur University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride change		Baseline and after 4 weeks	Yes
Primary	Total Cholesterol change		Baseline and after 4 weeks	Yes
Primary	HDL- Cholesterol change		Baseline and after 4 weeks	Yes
Primary	LDL- Cholesterol change		Baseline and after 4 weeks	Yes
Primary	hsCRP change		Baseline and after 4 weeks	Yes
Primary	TNF- a change		Baseline and after 4 weeks	Yes
Primary	IL-6 change		Baseline and after 4 weeks	Yes
Primary	adiponectin change		Baseline and after 4 weeks	Yes
Secondary	Fasting Blood Sugar change		baseline and after 4 weeks	Yes
Secondary	Blood Pressure change		Baseline and after 4 weeks	Yes
Secondary	Body Mass Index change		baseline and after 4 weeks	Yes