The effect of sesame-canola oil compared to sesame and canola oil on blood pressure, lipid profile and blood glucose control in patients with type 2 diabetes: A three-way randomized cross-over clinical trial
This study will be a randomized triple blind three-way cross-over trial which aims to investigate the effect of replacing the regular oil consumption of patients with type 2 diabetes with sesame-canola (a blend of sesame and canola oil) (SCO) in comparison with sesame oil (SO) and canola oil (CO) on blood pressure and cardiometabolic markers. Patients with type 2 diabetes will be selected to be entered into the study based on the inclusion criteria. All participants will receive a dietary prescription and recommendation to maintain a healthy diet during the study period. Then, they will be entered to a four week run-in period in which sunflower oil will be provided for regular oil consumption. After run-in period participants will be entered into the main phase of the study. Each intervention period will last for nine weeks, four weeks apart as wash-out period (in which sunflower oil will be provided). The participants will be randomized using statistical package for social sciences (SPSS) to receive SCO, SO or CO in each intervention period. SCO, SO, and CO will be provided for participants in the same packages labeled by a person who is not aware of the study objectives and protocol. Participants and personnel will be blinded to the intervention oils up to the end of the study period and analysis of the study results. Physical activity assessment (using three-day record), three-day weighted food record, anthropometric (including body weight, height, waist circumference and body fat percent) and blood pressure measurement will be conducted at the entrance, start, and the end of each intervention period. Blood samples (for assessment of lipid profile and glucose control markers) will also be taken from each participant at the start and the end of each intervention period. The change in lipid profile and blood glucose control markers will be compared between periods of SCO, SO and CO consumption, in crude and multivariable adjusted models.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091312571N6
Registration date:2016-11-14, 1395/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
Amin Salehi-Abargouei
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
abargouei@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences,Yazd, Iran.
Expected recruitment start date
2016-05-07, 1395/02/18
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sesame-canola oil compared to sesame and canola oil on blood pressure, lipid profile and blood glucose control in patients with type 2 diabetes: A three-way randomized cross-over clinical trial
Public title
The effect of sesame-canola oil compared to sesame and canola oil on patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants aged between 18-60 years old; who had at least 6-month and maximum 10 years history of type 2 diabetes based on clinical criteria; take oral anti-hyperglycemic agents and do not take insulin therapy; who have HbA1c values under 8%; without Known Cardiovascular Disease (Coronary Artery Disease, Stroke, Congestive heart disease) and Coronary artery bypass grafting (CABG); Kidney or Liver disease [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) three times more than normal values] history; history of cancer; not changed the dose of lipid lowering medications for at least 3 months prior starting the study; being pregnant;have intention to enter the study and fill the informed consent.
Exclusion criteria:
Participants who significantly change their dietary habits during the study period; Occurrence of pregnancy, cancer or cardiovascular diseases (CVDs); those who intend to discontinue the study with any reason.
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shahid Sadoughi University of Medical Sciences
Street address
Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8916978477
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SSU.REC.1395.25
2
Ethics committee
Name of ethics committee
Ethics committe of Shahid Sadoughi University of Medical Sciences
Street address
Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8916978477
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SSU.REC.1395.26
Health conditions studied
1
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Serum high density lipoprotein cholesterol (HDL-C)
Timepoint
start and the end of each intervention period
Method of measurement
Using Appropriate kits, by Alpha-Classic autoanalyzer
2
Description
Serum fasting blood sugar(FBS)
Timepoint
start and the end of each intervention period
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
3
Description
Serum low Density Lipoprotein cholesterol (LDL-C)
Timepoint
start and the end of each intervention period
Method of measurement
Using Appropriate kits, by Alpha-Classic autoanalyzer
4
Description
Serum Total cholesterol
Timepoint
start and the end of each intervention period
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
5
Description
Serum triglyceride level (TG)
Timepoint
start and the end of each intervention period
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
Secondary outcomes
1
Description
BMI(body mass index)
Timepoint
entrance and start and the end of each intervention period
Method of measurement
kg/m2
2
Description
Body Fat percent
Timepoint
entrance and start and the end of each intervention period
Method of measurement
by body composition analyzer
3
Description
Muscle mass percent
Timepoint
entrance and start and the end of each intervention period
Method of measurement
by body composition analyzer
4
Description
weight
Timepoint
entrance and start and the end of each intervention period
Method of measurement
by body Calibrated scale
5
Description
blood pressure
Timepoint
entrance and start and the end of each intervention period
Method of measurement
by Barometer
6
Description
hemoglobin A1c(HbA1c)
Timepoint
start and the end of each intervention period
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
7
Description
Lipoprotein(a)
Timepoint
start and the end of each intervention period
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
8
Description
Apo lipoprotein A (Apo A)
Timepoint
start and the end of each intervention period
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
9
Description
Apo lipoprotein B(Apo B)
Timepoint
start and the end of each intervention period
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
Intervention groups
1
Description
Intervention: Sesame-canola oli
Category
Lifestyle
2
Description
control: sesame oil
Category
Lifestyle
3
Description
Control: Canola oil
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mojgan Amiri
Street address
diabetes Research Center, Bahonar Square, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, shahid sadughi yazd University of Medical Sciences
Full name of responsible person
Dr. Amirhushang Mehrparvar
Street address
Chancellery for research, Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, shahid sadughi yazd University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Datis edible oil company
Full name of responsible person
Mr Ahmadi
Street address
Shahab complex, Daneshgah Boulevard, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Datis edible oil company
Proportion provided by this source
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
Nutrition and Food security Research Center, Faculty of Health, Shahid Sadoughi University of Medica
Full name of responsible person
Mojgan Amiri
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Postal code
8916978477
Phone
+98 35 3820 9100
Fax
Email
mojgan.amiri2015@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition and Food security Research Center, Faculty of Health, Shahid Sadoughi University of Medica
Full name of responsible person
Amin Salehi-Abargouei
Position
PhD in Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Postal code
8916978477
Phone
+98 35 3820 9100
Fax
Email
abargouei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition and Food security Research Center, Faculty of Health, Shahid Sadoughi University of Medica
Full name of responsible person
Mojgan Amiri
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Postal code
8916978477
Phone
+98 35 3820 9100
Fax
Email
mojgan.amiri2015@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)