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The effects of pomegranate seed oil supplementation on the PPAR gamma and GLUT4 genes expression and the serum levels of IL-6, TNF-α and hs-CRP inflammatory factors and Glycemic indexes in obese type 2 diabetic patients: randomized controlled clinical tri

Protocol summary

Study aim
determining the effects of pomegranate seed oil supplementation on the PPAR gamma and GLUT4 genes expression and the serum levels of IL-6, TNF-α and hs-CRP inflammatory factors and Glycemic indexes in obese type 2 diabetic patients
Design
this study will be done on 60 type 2 diabetic patients in both genders. Subjects will be randomly divided into two intervention and control groups by considering the inclusion criteria (age between 30 to 50 years, BMI greater than 30 and less than 40, and fasting glucose equal to or greater than 126) and non- inclusion criteria (Pregnant women, lactating women, hormone replacement therapy, taking TZD and insulin medications) of the study.
Settings and conduct
This randomized, controlled clinical trial is conducted on obese patients with type 2 diabetes who are referred to Tabriz University of Medical Sciences clinics with a duration of more than 6 months. After entering the study, the subjects will be divided into two groups of intervention and control by simple randomization.The intervention group will receive 3 gr pomegranate seed oil softgels) 1 gr each( daily and the control group will receive similar amounts of placebo (paraffin) for 8 weeks. People are asked to take a softgel with breakfast, lunch, and dinner. Five cc fasting blood samples will collect from all participants at the beginning and end of the intervention. All the participant will complete short form of the International Physical Activity Questionnaire and 3-day food record at the beginning and end of the intervention.
Participants/Inclusion and exclusion criteria
this study will be done on 60 type 2 diabetic patients in both genders. Inclusion criteria (age between 30 to 50 years, BMI greater than 30 and less than 40, and fasting glucose equal to or greater than 126) and Exclusion criteria (Pregnant women, lactating women, hormone replacement therapy, taking TZD and insulin medications)
Intervention groups
The intervention group will receive 3 gr pomegranate seed oil softgels) 1 gr each( daily and the control group will receive similar amounts of placebo (paraffin) for 8 weeks.
Main outcome variables
PPAR gamma and GLUT4 genes expression; The serum levels of IL-6, TNF-α and hs-CRP inflammatory factors; Glycemic indexes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100606004105N15
Registration date: 2017-12-27, 1396/10/06
Registration timing: registered_while_recruiting

Last update: 2017-12-27, 1396/10/06
Update count: 0
Registration date
2017-12-27, 1396/10/06
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of pomegranate seed oil supplementation on the PPAR gamma and GLUT4 genes expression and the serum levels of IL-6, TNF-α and hs-CRP inflammatory factors and Glycemic indexes in obese type 2 diabetic patients: randomized controlled clinical tri
Public title
Effect of pomegranate seed oil on obese type 2 diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
َAge between 30 to 50 years BMI greater than 30 and less than 40 Fasting glucose equal to or greater than 126 Having a willingness and ability to cooperate in the study
Exclusion criteria:
Pregnant women Lactating women, Patients under hormone therapy Patients who taking TZD or Insulin medications Patients who taking lipid-lowering medications Patients who taking weight loss medications Patients who didn't take antioxidants drugs (at least 3 months ago) Patients with impaired fat metabolism Patients who have allergies to pomegranate Patients who consumed less than 90% of pomegranate seed oil, changed their dose of medicine Patients who taking vitamins (D, A, B6), and omega 3 supplements Patients who do not have the desire or ability to continue studying
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience Sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
All capsules with same shapes and colors were placed by a third person who labeled the bottles with 2 codes which remained unknown to the researchers until the end of assays
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
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.TBZMED.REC.1396.748

Health conditions studied

1

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

2

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
obesity

Primary outcomes

1

Description
Fasting insulin
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Autoanalyzer kit

2

Description
Hemoglobin A1C
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Autoanalyzer kit

3

Description
high- sensitive C-reactive protein of Serum
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
ELISA

4

Description
serum interleukin-6
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
ELISA

5

Description
serum tumor necrosis factor-alpha
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
ELISA

6

Description
Glucose transporter type 4 gene expression
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Real time PCR

7

Description
peroxisome proliferator-activated receptors gamma gene expression
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Real time PCR

8

Description
Serum triglycerides
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Autoanalyzer kit

9

Description
serum low density lipoprotein cholesterol
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Autoanalyzer kit

10

Description
serum high density lipoprotein cholesterol
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Autoanalyzer kit

11

Description
total cholesterol
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Autoanalyzer kit

12

Description
fasting blood glucose
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Autoanalyzer kit

13

Description
insulin resistance
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
Homeostasis model (HOMA-IR)

14

Description
insulin sensitivity
Timepoint
Before and the end of the intervention (eighth week)
Method of measurement
QUICKI

Secondary outcomes

1

Description
body mass index
Timepoint
Before and at the end of the intervention (eighth week)
Method of measurement
the body mass divided by the square of the body height

2

Description
fat mass
Timepoint
Before and at the end of the intervention (eighth week)
Method of measurement
bioelectrical impedance

Intervention groups

1

Description
Placebo (Paraffin): 3 Soft Gel (1 gr each) with Meals of Breakfast, Lunch and Dinner for 8 weeks
Category
Placebo

2

Description
3 pomegranate seed oil soft gels (1 gr each) with Meals of Breakfast, Lunch and Dinner daily for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahar Clinic
Full name of responsible person
Yaser khajebishak
Street address
Tabriz- golgasht ST
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Phone
+98 41 3335 7584
Email
alipourb@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
Vice-chancellor for Research, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences
Full name of responsible person
Yaser khajebishak
Position
Ph.D. Student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Attar-e Nishaboori ST- Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 41 3441 5285
Fax
Email
khajebishaky@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences, Tabriz university of Mdical Sciences
Full name of responsible person
Dr. Beit Allah Alipour
Position
Professor of Nutrition, in Faculty of Nutrition and Food Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar-e Nishaboori ST, Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 41 3335 7584
Fax
Email
alipourb@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences
Full name of responsible person
Yaser khajebishak
Position
Ph.D. student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Attar-e Neishaboori ST-Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 41 3441 5285
Fax
Email
khajebishak.y@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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