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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091614680N1
Registration date:2013-11-22, 1392/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-22, 1392/09/01
Registrant information
Name
Farideh Shishehbor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8430
Email address
shishehbor-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2013-10-02, 1392/07/10
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of concentrated pomegranate juice consumption on lipid profile and inflammatory factors in patients with type 2 diabetes
Public title
The effects of concentrated pomegranate juice on inflammatory factors in type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: male or female 25 to 60 years old; having type 2 diabetes at least 6 month. Exclusion criteria: pregnancy; lactation; cardiac; hepatic; respiratory and 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 were excluded.
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapoor University of Medical Sciences
Street address
Vice Chancellor for Research and Technological Development, Ahvaz Jundishapoor University of Medical Sciences, Golestan Blv., Ahvaz
City
Ahvaz
Postal code
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
Ajums-REC.1392.54 B-9202
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E-11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Triglyceride
Timepoint
Baseline and after 4 weeks
Method of measurement
Spectrophotometry
2
Description
Total Cholesterol
Timepoint
Baseline and after 4 weeks
Method of measurement
Spectrophotometry
3
Description
HDL- Cholesterol
Timepoint
Baseline and after 4 weeks
Method of measurement
Spectrophotometry
4
Description
LDL- Cholesterol
Timepoint
Baseline and after 4 weeks
Method of measurement
Friedewald Formula
5
Description
hsCRP
Timepoint
Baseline and after 4 weeks
Method of measurement
Eliza
6
Description
TNF- α
Timepoint
Baseline and after 4 weeks
Method of measurement
Eliza
7
Description
IL-6
Timepoint
Baseline and after 4 weeks
Method of measurement
Eliza
8
Description
adiponectin
Timepoint
Baseline and after 4 weeks
Method of measurement
Eliza
Secondary outcomes
1
Description
Fasting Blood Sugar
Timepoint
baseline and after 4 weeks
Method of measurement
Spectrophotometry
2
Description
Blood Pressure
Timepoint
Baseline and after 4 weeks
Method of measurement
Sphygmomanometer
3
Description
Body Mass Index
Timepoint
baseline and after 4 weeks
Method of measurement
calculate
Intervention groups
1
Description
50 gr concentrated pomegranate juice with lunch and dinner meals for 4 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Maryam Zare
Street address
Ahvaz Jundishapour University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Maryam Zare
Position
MS candidate student
Other areas of specialty/work
Street address
Ahvaz Jundishapour University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 31 1335 9090
Fax
Email
zare.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Farideh Shishebor
Position
Nutrition PhD, Assistant professor, Ahvaz Jundishapour University of Medical Sciences
Other areas of specialty/work
Street address
Paramedics school, Ahvaz Jundishapour University of Medical Sciences , Golestan Blv., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
shishehbor-f@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Maryam Zare
Position
M.Sc condidate
Other areas of specialty/work
Street address
Ahvaz University of medical sciences
City
Ahvaz
Postal code
Phone
00
Fax
zare.m@ajums.ac.ir
Email
zare.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)