This randomized clinical trial is designed with aim to determine the effect of grape seed oil on inflammatory factors and insulin resistance in over weight and obese women. In this study, 44 women with body mass of 27 or greater without any recent surgery are divided in two intervention and placebo group with 22 subjects. Women in two intervention and placebo groups will eat daily 15% from purified grape seed oil and sun flower oil respectively for two months. For all of the Participants, personality questionnaire and 24 hours food recall will be filled for assessment of nutrient intake and food frequency questionnaire for food habit evaluation. All of them will be given weight loss diet with 500 Kcal reduction from their daily-needed amount of calorie. The anthropometrical measurements every two weeks and biochemical measurements at first and end of the study will be repeated. Therefore the effect of purified grape seed oil will be compared with sunflower oil.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110123320N2
Registration date:2011-12-10, 1390/09/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-10, 1390/09/19
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Research Center, Health and Nutrition Faculty, Tabriz University of Medical Sciences
Expected recruitment start date
2011-11-06, 1390/08/15
Expected recruitment end date
2012-02-04, 1390/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral grape seed oil consumption on inflammatory factors and insulin resistance in over weight and obese women
Public title
The effect of oral grape seed oil consumption on overweight and obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1- BMI equal or greater than 27; 2- following no weight loss or any special diet; 3-women with 20 until 50 years old. Exclusion criteria: 1- vitamin-mineral supplement consumption; 2- anti-inflammatory drugs consumption; 3- pregnancy or lactation; 4- being type 1 or 2 diabetes; 5-smoking; 6-recent illnesses; 7- recent surgery; 8- injuries.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabori Street
City
Tabriz
Postal code
Approval date
2011-10-17, 1390/07/25
Ethics committee reference number
9042
Health conditions studied
1
Description of health condition studied
over weight and obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Inflammatory factors
Timepoint
Beginning and end of the intervention
Method of measurement
TNF-α and hs-CRP measurement with special kits
2
Description
insulin level
Timepoint
Beginning and end of the intervention
Method of measurement
measurement with special kits
3
Description
Fasting blood glucose level
Timepoint
Beginning and end of the intervention
Method of measurement
enzymatic method
Secondary outcomes
1
Description
anthropometry
Timepoint
beginning, second, fourth, sixth and end of the intervention
Method of measurement
Waist circumference, Hip circumference and weight measurement
2
Description
Energy and nutrient intake
Timepoint
beginning, second, fourth, sixth week and end of the intervention
Method of measurement
nutrient intake questionnaire
Intervention groups
1
Description
Grape seed oil consumption up to 15% of daily calorie instead of sunflower oil for two months in intervention group
Category
Prevention
2
Description
Continue to consumption of sunflower oil up to 15% of daily calorie for two months in placebo group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykholrais clinic
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Research Center, Health and nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Ostadrahimi
Street address
Block B, Third Floor, Health And Nutrition Faculty, Tabriz University Of Medical Sciences , Attar Neyshabori Street Tabriz, East Azerbayjan,Iran, Islamic Republic Of
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional Research Center, Health and nutrition faculty, Tabriz 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
Nutritional Research Center, Health and nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Nutrition, PhD
Other areas of specialty/work
Street address
Health and Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1334 1113
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Health and nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Pardis Irandoost
Position
Master Science Student Of Nutrition
Other areas of specialty/work
Street address
Health and Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1334 1113
Fax
Email
pardis_irandoost@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Health and nutrition faculty
Full name of responsible person
Pardis Irandoost
Position
Master Science Student of Nutrition
Other areas of specialty/work
Street address
Health and Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)