Protocol summary

Summary
The aim of this randomized double blind clinical trial is to determine the effects of pomegranate juice on some blood biochemical parameters in type 2 diabetic patients. Fifty patients aged between 30-50 years old from both sexes are assigned into two groups. Patients in intervention group consume 250ml/day pomegranate juice and patients in control group consume 250ml/day water for 8 weeks. Anthropometric and blood pressure measurements,3 times 3-day food record and fasting blood samples are collected at the beginning and at the end of study. Fasting blood sugar, glycosylated hemoglobin, insulin, lipid profile, malondialdehyde (MDA), total antioxidant capacity (TAC), superoxide dismutase, glutathione peroxidase and hsCRP are measured. LDL and HOMA-IR are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904294424N1
Registration date: 2010-10-18, 1389/07/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-10-18, 1389/07/26
Registrant information
Name
Samira Babayian Amini
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 407 5580
Email address
ebrahimiemamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition research center, Tabriz University of Medical Sciences & Shadli Company
Expected recruitment start date
2010-05-31, 1389/03/10
Expected recruitment end date
2010-08-01, 1389/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pomegranate juice (no added sugar) consumption on lipid profile, inflammation factor and oxidative stress in overweight or obese patients with type 2 diabetes
Public title
The effects of pomegranate juice on type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: male or female, 30 to 50 years old, BMI between 25-35, having type 2 diabetes at least 6 month, taking metformin or glybanclamid, taking atrovastain, simvastatin or levostatin. Exclusion criteria: having the renal or hepatic failure, treatment With HRT, smoking, treatment with insulin, use of multivitamin-mineral 6 months prior to the study.
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golbad Ave
City
Tabriz
Postal code
Approval date
2010-09-27, 1389/07/05
Ethics committee reference number
8926

Health conditions studied

1

Description of health condition studied
diabetes mellitus 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
baseline and after 8 weeks
Method of measurement
spectrophotometry

2

Description
Hemoglobin A1c
Timepoint
baseline and after 8weeks
Method of measurement
Chromatography

3

Description
Insulin
Timepoint
baseline and after 8 weeks
Method of measurement
ELIZA

4

Description
HOMA-IR
Timepoint
Baseline and after 8weeks
Method of measurement
Formula

5

Description
Total Cholesterol
Timepoint
Baseline and after8 weeks
Method of measurement
Spectrophotometry

6

Description
Triglyceride
Timepoint
Baseline and after8 weeks
Method of measurement
Spectrophotometry

7

Description
HDL
Timepoint
Baseline and after 8 weeks
Method of measurement
Spectrophotometry

8

Description
LDL
Timepoint
Baseline and after 8weeks
Method of measurement
Friedewald Formula

9

Description
Malondialdehyde
Timepoint
Baseline and after 8 weeks
Method of measurement
Spectrophotometry

10

Description
Glutathione peroxidase
Timepoint
Baseline and after 8 weeks
Method of measurement
Spectrophotometry

11

Description
Superoxide dismutase
Timepoint
Baseline and after 8 weeks
Method of measurement
Spectrophotometry

12

Description
Total Antioxidant Capacity (TAC)
Timepoint
Baseline and after 8 weeks
Method of measurement
Spectrophotometry

13

Description
hsCRP
Timepoint
baseline and after 8 weeks
Method of measurement
immunotorbidometry

Secondary outcomes

1

Description
Dietary Factors
Timepoint
Baseline and after 8 weeks
Method of measurement
3-day food record

2

Description
Body Mass Index
Timepoint
Baseline and after 8 weeks
Method of measurement
Formula

3

Description
Blood Pressure
Timepoint
Baseline and after 8 weeks
Method of measurement
Sphygmomanometer

Intervention groups

1

Description
intervention Group:pomegranate juice,250 ml/day,8weeks
Category
Treatment - Drugs

2

Description
Control Group:water,250 ml/day,8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Endocrine Clinic
Full name of responsible person
Dr. Ebrahimi
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ebrahimi
Street address
Golbad street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Nutrition research center, Tabriz university of Medical sciences
Full name of responsible person
Dr Alireza Ostadrahimi
Street address
Faculty of Health & Nutrition, Atar-Neishaboori st, Golgasht st
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition research center, Tabriz university of Medical sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

3

Sponsor
Name of organization / entity
Shadli company
Full name of responsible person
Mrs Soltani
Street address
Urumie
City
Urumie
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shadli company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Health and Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ebrahimi
Position
Associate Professor in Department of nutrition in society
Other areas of specialty/work
Street address
Attar Neyshabouri Street, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
ebrahimimamagani@tbzmed.ac.ir , samira_b_amini@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samira Babayian Amini
Position
MSc Student of Nutrition Science
Other areas of specialty/work
Street address
Attar Neyshabouri Street, Golgasht Street
City
Tabriz
Postal code
Phone
+98 914 407 5580
Fax
Email
samira_b_amini@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samira Babayian Amini
Position
MSc Student of Nutrition Science
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
samira_b_amini@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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