Protocol summary

Summary
The purpose of this research is to study the effect of olive oil rich diet consumption on serum omentin concentration in overweight women. The research is a randomized clinical trial (cross-over). Inclusion Criteria: females age between 20-50-year, BMI between 25-29/9, Exclusion criteria: pregnancy, breast feeding, history of coronary artery disease, diabetes, metabolic diseases, arthritis, lupus, GI diseases, hypertension, any kind of infection, trauma, thyroid diseases, history of using drugs, such as (anti hypertension, anti hyperlipidemia, anti-inflammation, anti diabetic agents, drugs for weight reduction, OCP, corticosteroids). 16 healthy females will participate in the study and will be randomly divided into two groups. Group 1 will receive a diet with energy restriction (-500 kcal), 51% carbohydrate, 15% protein, 34% fat, 16% SFA, 10% PUFA, 8% MUFA. Group 2 will receive a diet with energy restriction (-500 kcal) and rich in extra virgin olive oil with composition: 51% carbohydrate, 15% protein, 34% fat, 8% SFA, 10% PUFA, 16% MUFA. The subjects in each group will follow the diet for six weeks and after two weeks for wash out period the two groups will change place with regard the diet they are receiving. They will follow the new diet for another six weeks. At the beginning and the end of each phase a blood sample (10 cc) will be collected and anthropometric indices will be measured. In addition, a 24-h recall and a physical activity questionnaire will be completed by subjects every other week.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812223550N1
Registration date: 2009-09-23, 1388/07/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-09-23, 1388/07/01
Registrant information
Name
Akram Kabiry
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 33 5527 1917
Email address
akabiry@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2009-11-06, 1388/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of olive oil rich diet consumption on serum omentin concentration in overweight women
Public title
The effect of olive oil rich diet consumption on serum omentin concentration
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion Criteria: married women age: 20-50-year, BMI between 25-29/9, absence of clinical signs or symptoms of coronary artery disease, diabetes, metabolic diseases, arthritis, lupus, GI diseases, hypertension, any kind of infection, trauma, thyroid diseases, without history of using drugs, such as anti- hypertensive, anti hyperlipidemia, anti-inflammatory, anti diabetic agents, drugs for weight reduction, OCP, corticosteroids, not pregnancy and lactation, not smoking. Exclusion criteria: pregnancy, breast feeding, presence of any disease and use of drugs that mentioned above, don’t follow the diets
Age
From 20 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ghods Ave.
City
Tehran
Postal code
1417613151
Approval date
empty
Ethics committee reference number
10265

Health conditions studied

1

Description of health condition studied
Serum omentin concentration in owerweight women
ICD-10 code
-
ICD-10 code description
-

2

Description of health condition studied
Overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Serum omentin concentration
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Elisa kit

Secondary outcomes

1

Description
Plasma adiponectin concentration
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Elisa kit

2

Description
C- reactiv protein
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Elisa kit

3

Description
Insulin
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Elisa kit

4

Description
Fasting blood glucose
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Elisa kit

5

Description
Lipid profile(cholestrol-triglicerid-HDL-LDL)
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Elisa kit

6

Description
Weight
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Seca digital scale

7

Description
Body mass index
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Calculate

8

Description
Body fat mass
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Bioempedance device

9

Description
Waist and hip circumference
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Meter

10

Description
Waist to hip ratio
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Calculate

11

Description
Blood pressure
Timepoint
At the beginning and at the end of phase one and two
Method of measurement
Manometer

Intervention groups

1

Description
Diet rich in olive oil with composition:51% carbohydrate.15% protein. 34% fat.8% SFA.10% PUFA.16% MUFA for six weeks
Category
Treatment - Drugs

2

Description
Common diet with composition:51% carbohydrate.15% protein. 34% fat.16% SFA.10% PUFA.8% MUFA for six weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mohammad Rasoulallah Hospital of Mobarakeh
Full name of responsible person
Akram Kabiri
Street address
Mohammad Rasolallah Hospital mobarakeh, Safaeeh, Mobarakeh, Esfahan
City
Mobarakeh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Javad Hosseinzadeh
Street address
Faculty of Public health,Tehran University of Medical Sciences, Enghelab square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Faculty of Public health,Tehran University of Medical Sciences
Full name of responsible person
Fahimeh Haghighatdoost
Position
Master of Nutritional Science
Other areas of specialty/work
Street address
Faculty of Public health,Tehran University of Medical Sciences, Enghelab square
City
Tehran
Postal code
Phone
+98 31 1230 4119
Fax
Email
f_haghighatdoost@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition and biochemistry group, faculty of Public health,Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Hosseinzadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Nutrition and biochemistry group, faculty of Public health,tehran University of Medical Sciences, Enghelab square
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
Email
hosseinzadeh.mdphd@yahoo.com ; mjha3@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition and biochemistry group, faculty of Public health,Tehran University of Medical Sciences
Full name of responsible person
Fahimeh Haghighatdoost
Position
Master of Nutritioal Science
Other areas of specialty/work
Street address
Nutrition and biochemistry group, faculty of Public health,tehran University of Medical Sciences, Enghelab square
City
Tehran
Postal code
Phone
+98 31 1230 4119
Fax
Email
f_haghighatdoost@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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