Comparison of the effect of consuming olive oil and sunflower oil as the substitute for a portion of daily dietary fat on fasting and postprandial blood glucose and lipid profile in type 2 diabetic female patients
This study is conducted to compare the effect of consuming olive oil and sunflower oil as the substitute for a portion of daily dietary fat on fasting and postprandial blood glucose and lipid profile in type 2 diabetic female patients. This randomized crossover clinical trial is conducted on 20 postmenopausal women less than 60 years old with type 2 diabetes. Their average daily intake of hydrogenated oil is measured by completing a 3 day 24-hour dietary recall. Then, the patients randomly are assigned into 2 groups, consuming either olive oil or sunflower oil (instead of hydrogenated oil) for 3 weeks. After a washout period of 3 weeks, subjects are switched to the other oil for the next 3 weeks. Anthropometric measurements and biochemical tests are done at the beginning of the study, and at the end of the weeks 3, 6, and 9. Postprandial biochemical tests are performed after the consumption of the patient's usual breakfast. Every 3 week, a 1day 24-hour dietary recall is also obtained.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808202697N1
Registration date:2010-01-05, 1388/10/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-01-05, 1388/10/15
Registrant information
Name
Saloomeh Armin
Name of organization / entity
Shaheed Beheshti University of Medical Sciences - Faculty of Nutrition Sciences and Food Technology
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0658
Email address
s.armin@nnftri.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaheed Beheshti University of Medical Sciences and Health Services -School of Nutrition Sciences and Food Technology - Department of Human Nutrition
Expected recruitment start date
2009-12-07, 1388/09/16
Expected recruitment end date
2010-02-08, 1388/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of consuming olive oil and sunflower oil as the substitute for a portion of daily dietary fat on fasting and postprandial blood glucose and lipid profile in type 2 diabetic female patients
Public title
Comparison of the effect of consuming olive oil and sunflower oil on blood glucose and lipid profile in type 2 diabetic female patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
-Type II diabetes (FBS>126mg/dl)
-Menopause women. Less than 60 years old
-Not taking insulin and any drug that affects lipids metabolism (lipid-lowering drugs, multivitamins, hormones and beta-blockers)
-No heart, liver, kidney diseases, no hypothyroidism or hyperthyroidism
-Consumption of hydrogenated vegetable oil and no consumption of olive oil, sunflower oil and corn oil during the three weeks before starting the study
-No abusing of smoke, alcohol or drugs
Exclusion criteria
-Not following the recommended diet changes
-More or less than 5 percent changes in the body weight during one month
-Occurrence of gastrointestinal, liver or ischemic heart diseases
-Any changes in taking medicines or starting to take insulin
-Taking any drug that affects lipids metabolism (lipid-lowering drugs, multivitamins, hormones and beta-blockers) during study
-Changes in physical activity
Age
To 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
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
National Nutrition and Food Technology Research Institute
Street address
No 46, Arghavan-e-gharbi St., Farahzadi Blv., Shahrak-e-Ghods.
City
Tehran
Postal code
19395-4741
Approval date
2009-11-29, 1388/09/08
Ethics committee reference number
033A01
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar (FBS)
Timepoint
At the beginning of the study, and at the end of the weeks 3, 6, and 9.
Method of measurement
FBS, PPBS measurment
Secondary outcomes
1
Description
Blood Lipids
Timepoint
At the beginning of the study, and at the end of the weeks 3, 6, and 9.
Method of measurement
Fasting and Postprandial Blood Triglyceride, Total Cholesterol , LDL-C, HDL-C, TC/HDLC, LDL-C/HDL-C, TG/HDL-C levels measurement
Intervention groups
1
Description
Olive oil - 40% of total dietary fat intake - for 3 weeks
Category
Treatment - Other
2
Description
Sunflower oil - 40% of total dietary fat intake - for 3 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medial Sciences, Endocrine and Metabolism Institute
Full name of responsible person
Dr. Abbas Rashad
Street address
3rd floor, Next to Firuzgar Hospital, Shahid Valadi St., Vali-e-Asr Sq., Vali-e-Asr St. .
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Beheshti University of Medical Sciences -Faculty of Nutrition Sciences and Food Technology
Full name of responsible person
Dr. Farideh Tahbaz
Street address
No 46, Arghavan-e-gharbi St., Farahzadi Blv., Shahrak-e-Ghods.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Beheshti University of Medical Sciences -Faculty of Nutrition Sciences and Food Technology
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
Shaheed Beheshti University of Medical Sciences - Faculty of Nutrition Sciences and Food Technology
Full name of responsible person
Saloomeh Armin
Position
M.Sc. in Nutrition Sciences
Other areas of specialty/work
Street address
No 46, Arghavan-e-gharbi St., Farahzadi Blv., Shahrak-e-Ghods.
City
Tehran
Postal code
193954741
Phone
+98 21 2236 0658
Fax
+98 21 2237 6470
Email
s.armin@nnftri.ac.ir
Web page address
www.nnftri.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Beheshti University of Medical Sciences - Faculty of Nutrition Sciences and Food Technology
Full name of responsible person
Dr. Forough Azam Taleban
Position
Professor, Department of Human Nutrition
Other areas of specialty/work
Street address
No 46, Arghavan-e-gharbi St., Farahzadi Blv., Shahrak-e-Ghods.
City
Tehran
Postal code
19395-4741
Phone
+98 21 2235 7484
Fax
+98 21 2236 0660
Email
f.taleban@nnftri.ac.ir
Web page address
www.nnftri.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Beheshti University of Medical Sciences , National Nutrition and Food Technology Research In
Full name of responsible person
Zinat Kamali
Position
M.Sc. in Nutrition Sciences
Other areas of specialty/work
Street address
No 46, Arghavan-e-gharbi St., Farahzadi Blv., Shahrak-e-Ghods.
City
Tehran
Postal code
193954741
Phone
+98 21 2236 0658
Fax
+98 21 2237 6470
Email
z.kamali@nnftri.ac.ir
Web page address
www.nnftri.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)