Patients will randomly be assigned to one of three groups: 1. receiving 30 grams canola oil for 2 months; 2. receiving 30 grams soybean oil for 2 months; 3. control group ( consume their usual dietary fat). A 24-hour questionnaire in the first day, end of first month and end of second month will be completed for each patient. 10 ml blood will be obtained from every patient at beginning and at the end of second month and serum will be separated for analysis of following parameters: FBS, HbA1c, Triglyceride, Cholesterol, HDL, LDL, VLDL, CBC, ESR, and CRP.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012062510110N1
Registration date:2012-07-23, 1391/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-23, 1391/05/02
Registrant information
Name
Mahmoud Ali Kaykhaei
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1341 1296
Email address
keikhaeim@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2012-07-15, 1391/04/25
Expected recruitment end date
2013-01-14, 1391/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of canola oil and soybean oil on biochemical markers in overweight and obese patients with type 2 diabetes mellitus
Public title
Investigation of effects of canola oil and soy bean oil in diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Overweight or obese type 2 diabetes patients; 30 to 65 years old. Exclusion: Hyperglycemias not due to diabetes; liver, thyroid, kidney diseases; treatment with insulin; acute infections; anti lipid drugs; beta blockers; BMI≤ 24.9, BMI≥40.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Dr. Hesabi Sq, Pardis Building
City
Zahedan
Postal code
Approval date
2011-10-25, 1390/08/03
Ethics committee reference number
90-1477
Health conditions studied
1
Description of health condition studied
type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
2
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Blood Pressure
Timepoint
Beginning and 2 months after intervention
Method of measurement
Mercury sphigmomanometer
2
Description
Body Mass Index
Timepoint
Beginning and 2 months after intervention
Method of measurement
Measurment of Height and Weight and calculation by formula: Weight/Height2
3
Description
Fasting Glucose
Timepoint
Beginning and 2 months after intervention
Method of measurement
Available commercial kit
4
Description
HbA1c
Timepoint
Beginning and 2 months after intervention
Method of measurement
Available commercial kit
5
Description
Serum Lipids( TG,Chol, LDL, HDL, VLDL)
Timepoint
Beginning and 2 months after intervention
Method of measurement
Available commercial kit
6
Description
Complete Blood Count (CBC)
Timepoint
Beginning and 2 months after intervention
Method of measurement
Cell Counter
7
Description
Erythrocyte Sedimentation Rate (ESR)
Timepoint
Beginning and 2 months after intervention
Method of measurement
ESR Pipette
8
Description
CRP
Timepoint
Beginning and 2 months after intervention
Method of measurement
Available commercial kit
Secondary outcomes
1
Description
Inflammatory and Antioxidant markers
Timepoint
Beginning and 2 months after intervention
Method of measurement
Available commercial kits
Intervention groups
1
Description
Intervention 1 canola oil 30 grams daily for 2 months
Category
Treatment - Other
2
Description
Intervention 2 soybean oil 30 grams daily for 2 months
Category
Treatment - Other
3
Description
Control group Continue their previous diet for 2 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Dr. Mansour Shahraki
Street address
Aliasghar Hospital, Azadi Ave.
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ms. Soodabeh Hashemzehi
Street address
Deputy of Research, Pardis
City
Zahedan
Grant name
90
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mansour Shahraki
Position
PhD in Nutrition/ Educator
Other areas of specialty/work
Street address
Dept. of Nutrition, Medical School
City
Zahedan
Postal code
Phone
Fax
Email
shahrakimansour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mansour Shahraki
Position
PhD in Nutrition/ Educator
Other areas of specialty/work
Street address
Dept. of Nutrition, School of Medicine
City
Zahedan
Postal code
Phone
Fax
Email
shahrakimansour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Ali Kaykhaei
Position
Endocrinologist/ Educator
Other areas of specialty/work
Street address
Dept. of Medicine, Ali ebb abitaleb Hospital
City
Zahedan
Postal code
Phone
Fax
Email
mazyar44@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)