The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
50 gr concentrated pomegranate juice
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Pomegranate, Inflammation, lipid profiles
Eligibility Criteria
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
Sites / Locations
- Ahvaz Jundishapoor University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
50 gr concentrated pomegranate juice
Arm Description
Outcomes
Primary Outcome Measures
Triglyceride change
Total Cholesterol change
HDL- Cholesterol change
LDL- Cholesterol change
hsCRP change
TNF- α change
IL-6 change
adiponectin change
Secondary Outcome Measures
Fasting Blood Sugar change
Blood Pressure change
Body Mass Index change
Full Information
NCT ID
NCT02024516
First Posted
December 14, 2013
Last Updated
December 30, 2013
Sponsor
Ahvaz Jundishapur University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02024516
Brief Title
The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahvaz Jundishapur University of Medical Sciences
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Pomegranate, Inflammation, lipid profiles
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
8. Arms, Groups, and Interventions
Arm Title
50 gr concentrated pomegranate juice
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
50 gr concentrated pomegranate juice
Primary Outcome Measure Information:
Title
Triglyceride change
Time Frame
Baseline and after 4 weeks
Title
Total Cholesterol change
Time Frame
Baseline and after 4 weeks
Title
HDL- Cholesterol change
Time Frame
Baseline and after 4 weeks
Title
LDL- Cholesterol change
Time Frame
Baseline and after 4 weeks
Title
hsCRP change
Time Frame
Baseline and after 4 weeks
Title
TNF- α change
Time Frame
Baseline and after 4 weeks
Title
IL-6 change
Time Frame
Baseline and after 4 weeks
Title
adiponectin change
Time Frame
Baseline and after 4 weeks
Secondary Outcome Measure Information:
Title
Fasting Blood Sugar change
Time Frame
baseline and after 4 weeks
Title
Blood Pressure change
Time Frame
Baseline and after 4 weeks
Title
Body Mass Index change
Time Frame
baseline and after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Zare, MS condidate
Phone
+989132275832
Email
zare.m@ajums.ac.ir
Facility Information:
Facility Name
Ahvaz Jundishapoor University of Medical Sciences
City
Ahvaz
State/Province
Khoozestan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farideh Shishebor, Nutrition PhD
Phone
+986113738319
Email
shishehbor-f@ajums.ac.ir
First Name & Middle Initial & Last Name & Degree
Maryam Zare, MS condidate
12. IPD Sharing Statement
Learn more about this trial
The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes
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