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Comparing the effect of canola oil and olive oil on blood lipids, oxidative stress, insulin resistance, blood pressure and inflammation in women with type 2 diabetes

Protocol summary

Summary
The main objective of the study: Comparing the effect of canola oil and olive oil on blood lipids, oxidative stress, insulin resistance, blood pressure and inflammation on the population of women with type 2 diabetes. Study design: Non-randomized, not blinded, without a placebo control, single center. Study population: Women with type 2 diabetes. Conditions for Inclusion criteria: "female gender; at least 6 months history of diabetes; routine consumption of sunflower oil". Conditions for exclusion: "needing blood fat-lowering drugs; using insulin; Existence of thyroid disorders; kidney and liver disease; cardiovascular disease; participating in other studies in 6 months before; history of allergies; consumption of corticosteroids, immunosuppressive NSAIDs, cyclosporine and warfarin; Smoking; alcohol use; Having LDL over 160 and Having TG over 400". Sample size: 75 people. Intervention:They are randomly divided into three groups by balanced block. In group, 30 grams of olive or canola or sunflower oil daily is given for 8 weeks. Time intervention: 8 weeks. Primary outcome: Lipid profile. Secondary outcome: Oxidative stress, resistance insulin, blood pressure, inflammation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062722818N1
Registration date: 2016-02-12, 1394/11/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-12, 1394/11/23
Registrant information
Name
Masume Atefi
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 25 3292 9575
Email address
stud0386015376@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellery for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of canola oil and olive oil on blood lipids, oxidative stress, insulin resistance, blood pressure and inflammation in women with type 2 diabetes
Public title
Comparison of olive oil and canola oil on the lipid profile in patients with type 2 diabetes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: female gender; at least 6 months history of diabetes; routine consumption of sunflower oil. Exclusion criteria: needing blood fat-lowering drugs; using insulin; Existence of thyroid disorders; kidney and liver disease; cardiovascular disease; participating in other studies in 6 months before; history of allergies; consumption of corticosteroids, immunosuppressive; NSAIDs; cyclosporine; warfarin; Smoking; alcohol use; Having LDL over 160 and Having TG over 400.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2015-06-05, 1394/03/15
Ethics committee reference number
IR.SUMS.REC.1394.27

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E00,E90
ICD-10 code description
Nutrional, endocrine and metabolic diseases

Primary outcomes

1

Description
Lipid profile
Timepoint
Before and after the intervention
Method of measurement
Blood test

Secondary outcomes

1

Description
Oxidative stress, insulin resistance, blood pressure and inflammation
Timepoint
Before and after the intervention.
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group 1: 30 grams daily olive oil from Famila brand for 8 weeks
Category
Treatment - Other

2

Description
Intervention group 2: 30 grams daily canola oil from Ladan brand for 8 weeks
Category
Other

3

Description
Control group: 30 grams daily sunflower oil from Ladan Brand for 8 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Dr. Gholamreza Pishdad
Street address
Motahari Clinic, Namazi Square, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellery for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hadi Imanieh
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Masume Atefi
Position
M.Sc student in major of Health Sciences in Nutrition
Other areas of specialty/work
Street address
No. 15, 15th Alley, Mohammad Amin Boulevard, Qom
City
Qom
Postal code
Phone
+98 25 3292 9575
Fax
Email
atefi.masume@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masume Atefi
Position
M.Sc student in major of Health Sciences in Nutrition
Other areas of specialty/work
Street address
No. 15, 15th Alley, Mohammad Amin Boulevard, Qom
City
qom
Postal code
Phone
+98 25 3292 9575
Fax
Email
atefi.masume@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masume Atefi
Position
M.Sc student in major of Health Sciences in Nutrition
Other areas of specialty/work
Street address
No. 15, 15th Alley, Mohammad Amin Boulevard, Qom
City
Qom
Postal code
Phone
+98 25 3292 9575
Fax
Email
atefi.masume@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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