Effects of Pomegranate juice consumption on serum vascular and systematic inflammation factors, advanced glycation end products, NF-kB and Sirtuin1 activity in mononuclear cells in type2 diabetic patients
Cardiovascular diseases, nephropathy, blindness and amputation are the main complications of diabetes mellitus. These complications are mainly because of micro and macro angiopathy. High serum concentrations of oxidative stress, inflammation markers and advanced glycated end products are important risk factors for the development of diabetic complications. Pomegranate juice has antioxidant and anti- inflammatory properties. The purpose of this study is to determine the effects of pomegranate juice consumption on serum vascular and systematic inflammation factors, advanced glycation end products, NF-kB and Sirtuin1 activity in mononuclear cells in type2 diabetic patients. This study is a randomized double blind clinical trial performs on 48, 40-65 years old diabetic patients recruit from “Special Diabetic Affairs Foundation”. The patients are randomly allocated either to pomegranate juice consumption group or control group. PJ and control group will ask to consume 240 ml/day of PJ (without added sugar or additives) or a control beverage of similar color and energy and glucose content for 3 months. The questionnaires of general characters and three days 24-hour food recall will be completed by interview. Anthropometric measurements will be measured and 20 ml blood collected from each patient after 12-14h overnight fasting, at baseline and at the end of the study. Data will be analyzed using SPSS software. Independent-T-test will be used to compare pre and post intervention variables between groups. Covariance analysis will be used to compare blood parameters of two groups at the end of the study, adjusted for baseline measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206144010N8
Registration date:2012-07-12, 1391/04/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-12, 1391/04/22
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute of Nutrition And Food Sciences ; Research Institute for Endocrine Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-07-21, 1391/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Pomegranate juice consumption on serum vascular and systematic inflammation factors, advanced glycation end products, NF-kB and Sirtuin1 activity in mononuclear cells in type2 diabetic patients
Public title
Effects of pomegranate juice consumption on diabetes complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Diabetes type 2; 40-65 years old; BMI=18.5-30; Control of diabetes only by oral agents. Exclusion criteria: Liver and kidney diseases; Inflammatory diseases; Consumption of multivitamin and/or mineral supplements in the past 3 months; Consumption of corticosteroid, anti-inflammatory, non-steroid medications; Changing in type and dosage of used medications during the study; Changing in physical activity type and levels, during the study.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
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
Institute of Nutrition and Food Sciences
Street address
No 9, West Arghavan, Farahzadi Blvd, Shahrak Qods
City
Tehran
Postal code
1981619573
Approval date
2011-11-28, 1390/09/07
Ethics committee reference number
043435
Health conditions studied
1
Description of health condition studied
diabetes type 2
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
TNF-α
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/L
2
Description
hs-CRP
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/mL
3
Description
IL-6
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/L
4
Description
ICAM-1
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/mL
5
Description
VCAM-1
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/mL
6
Description
E-selectin
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/mL
7
Description
Pentosidine
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/mL
8
Description
Carboxy Methyl Lysin
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/mL
9
Description
HbA1C
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
Cromatography, Percent
10
Description
Glucose
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
calorimetry, mg/dl
11
Description
Insulin
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA, mU/L
12
Description
HOMA-IR
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
Calculate,(glucose×Insulin)/22.5
13
Description
NF-kB activity
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA
14
Description
Srtuin1 activity
Timepoint
at baseline and after 3 months at the end of the study
Method of measurement
ELISA , ng/mL
Secondary outcomes
empty
Intervention groups
1
Description
240 ml/day of PJ (without added sugar or additives) providing 126 Kcal, fat 0g, protein 1.4 g, and 23.5 g sugar for 3 months
Category
Other
2
Description
240 ml/day of a control beverage of similar color and energy and glucose content for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Nutrition Sciences and Food technology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golbon Sohrab
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Institute of Nutrition Sciences and Food technology
Full name of responsible person
Dr Majid Hajifaraji
Street address
No 9, West Arghavan, Farahzadi Blvd, Shahrak Qods
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute of Nutrition Sciences and Food technology
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
Research Institute for Endocrine Sciences
Full name of responsible person
professor Fereidoun Azizi
Street address
No 24, Parvaneh St., Yaman St., Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine 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
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nutrition Sciences and Food technology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golbon Sohrab
Position
PhD student in Nutrition Sciences
Other areas of specialty/work
Street address
No 9, West Arghavan, Farahzadi Blvd, Shahrak Qods
City
Tehran
Postal code
Phone
+98 21 4445 0097
Fax
Email
golbonsohrab@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golbon Sohrab
Position
PhD student in Nutrition Sciences
Other areas of specialty/work
Street address
No 9, West Arghavan, Farahzadi Blvd, Shahrak Qods
City
Tehran
Postal code
Phone
+98 21 4445 0097
Fax
Email
golbonsohrab@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)