Protocol summary
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Study aim
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To investigate the effect of replacing the regular oil consumption of participant (people with diabetes and their spouses) with sesame-canola (a blend of sesame and canola oil) in comparison with sesame oil and canola oil on blood pressure and cardiometabolic markers.
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Design
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Three-way randomized cross-over clinical trial
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Settings and conduct
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This study will be conducted at diabetes research center. All three types of oils 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 oil. Physical activity assessment, three-day weighted food record, anthropometric and blood pressure measurement will be conducted at the entrance, start, and the end of each intervention period and blood samples will also be taken from each participant (people with diabetes and their spouses) at the start and the end of each intervention period.
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Participants/Inclusion and exclusion criteria
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Patients with type 2 diabetes mellitus aged 18-60 years will be entered into the present study. each participant will enter the study with his/her spouse. Participants on insulin therapy or a history of cardiovascular, kidney and liver diseases, and cancer will not be entered to the study.
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Intervention groups
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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 a software to receive sesame, canola and sesame-canola oils in each intervention period.
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Main outcome variables
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Serum total cholesterol , triglyceride , high density lipoprotein cholesterol, low Density Lipoprotein cholesterol, and fasting blood sugar
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016091312571N6
Registration date:
2016-11-14, 1395/08/24
Registration timing:
registered_while_recruiting
Last update:
2018-05-15, 1397/02/25
Update count:
1
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Registration date
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2016-11-14, 1395/08/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shahid Sadoughi University of Medical Sciences,Yazd, Iran.
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Expected recruitment start date
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2016-05-07, 1395/02/18
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Expected recruitment end date
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2017-09-22, 1396/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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 and their spouse: A three-way randomized cross-over clinical trial
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Public title
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The effect of sesame-canola oil compared to sesame and canola oil on patients with type 2 diabetes and their spouse
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Adults aged between 18-60 years old
With clinically diagnosed type 2 diabetes for at least 6-month and maximum of 10 years
With hemoglubin A1C lower than 8 percent
Only take oral anti-hyperglycemic agents for the treatment
have intention to enter the study and fill the informed consent
Exclusion criteria:
Being on insulin therapy
History of known Cardiovascular Diseases (Coronary Artery Disease, Stroke, Congestive heart disease)
Coronary artery bypass grafting (CABG)
History of kidney or liver disease [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) three times more than normal values]
history of cancer
Changing the dose of lipid lowering medications for at least 3 months prior starting the study
being pregnant
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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As a three-way randomized controlled clinical trial the eligible participants will be randomly assigned to one of six following rolling methods using the statistical package for social sciences software (SPSS): 1) Sesame-canola, sesame, canola; 2) Sesame-canola, canola, sesame; 3)Canola, sesame-canola, sesame; 4)Canola, sesame, sesame-canola; 5)Sesame, sesame-canola, canola and 6)Sesame, canola, sesame-canola.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this study, blinding will be done for treatment oils for both researchers and participants. The oils will be given in the same 2.5-liter bottles and will be coded for each oils (canola, sesame and sesame-canola) by someone who are not enroll in the study design .
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-05-29, 1395/03/09
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Ethics committee reference number
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IR.SSU.REC.1395.25
2
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Ethics committee
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Approval date
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2016-05-29, 1395/03/09
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Ethics committee reference number
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IR.SSU.REC.1395.26
Health conditions studied
1
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Description of health condition studied
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Non-insulin-dependent diabetes mellitus
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ICD-10 code
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E11
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ICD-10 code description
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Non-insulin-dependent diabetes mellitus
2
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Description of health condition studied
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Spouses
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Serum high density lipoprotein cholesterol (HDL-C)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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Using Appropriate kits, by Alpha-Classic autoanalyzer
2
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Description
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Serum fasting blood sugar(FBS)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
3
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Description
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Serum low Density Lipoprotein cholesterol (LDL-C)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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Using Appropriate kits, by Alpha-Classic autoanalyzer
4
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Description
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Serum Total cholesterol
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
5
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Description
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Serum triglyceride level (TG)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
Secondary outcomes
1
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Description
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BMI(body mass index)
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Timepoint
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entrance and start and the end of each intervention period
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Method of measurement
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kg/m2
2
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Description
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Body Fat percent
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Timepoint
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entrance and start and the end of each intervention period
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Method of measurement
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by body composition analyzer
3
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Description
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Muscle mass percent
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Timepoint
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entrance and start and the end of each intervention period
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Method of measurement
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by body composition analyzer
4
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Description
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weight
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Timepoint
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entrance and start and the end of each intervention period
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Method of measurement
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by body Calibrated scale
5
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Description
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blood pressure
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Timepoint
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entrance and start and the end of each intervention period
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Method of measurement
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by Barometer
6
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Description
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Insulin
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate ELISA kit.
7
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Description
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Lipoprotein(a)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
8
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Description
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Apo lipoprotein A (Apo A)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
9
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Description
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Apo lipoprotein B(Apo B)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
10
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Description
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Alkaline phosphatase ( ALP)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
11
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Description
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alanine aminotransferase (ALT)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
12
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Description
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aspartate aminotransferase (AST)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
13
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Description
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gama glutamil transferase (GGT)
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
14
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Description
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Urea
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
15
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Description
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creatinine
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Timepoint
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start and the end of each intervention period
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Method of measurement
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using Appropriate kits, by Alpha-Classic autoanalyzer
Intervention groups
1
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Description
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Intervention: Sesame-canola oli
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Category
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Lifestyle
2
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Description
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control: sesame oil
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Category
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Lifestyle
3
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Description
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Control: Canola oil
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for Research, shahid sadughi yazd University of Medical Sciences
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Proportion provided by this source
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53
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Neshatavar food industry (Datis)
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Proportion provided by this source
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47
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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baseline and after treatment data values of primary and secondary outcome variables will be available for researchers.
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When the data will become available and for how long
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Data will be available after the summary data become published.
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To whom data/document is available
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The data will be available for all researchers interested in the subject.
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Under which criteria data/document could be used
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Data will be available if the interested researcher(s) fills the proposal for a joint project and the sponsor of the study (Shahid Sadoughi University of Medical Sciences) confirms the protocol of the project.
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From where data/document is obtainable
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The data can be obtained from Dr. Amin Salehi-Abargouei, Ph.D. in Nutrition Department of Nutrition Faculty of Public Health Sahid Sadoughi University of Medical Sciences Yazd, PO Code 8915173160 Iran Tel:+98-35-31492229 Fax:+98-35-38209119 Email: abargouei@ssu.ac.ir Alternate email: abargouei@gmail.com
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What processes are involved for a request to access data/document
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The interested investigators should provide a brief description of the data needed and their reason for asking the data by contacting the principal investigator. The principal investigator will assess the possibility of sharing the data and if applicable will ask for a joint proposal. The joint proposal will be sent to the vice chancellery for research, ShahidSadoughi University of Medical Sciences (the sponsor) and the data will be sent by the principal investigator if the sponsor confirms the cooperation.
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Comments
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