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IRCT2016091312571N6 IRCT 2016-11-14 Vice Chancellor for Research, shahid sadughi yazd University of Medical Sciences The effect of sesame-canola oil compared to sesame and canola oil on patients with type 2 diabetes and their spouse 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 2016-05-07 anticipated 100 Complete https://irct.ir/trial/12622 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: 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, Blinding description: 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 . N/A Condition 1: Non-insulin-dependent diabetes mellitus. Condition 2: Spouses. Intervention 1: Intervention: Sesame-canola oli. Intervention 2: control: sesame oil. Intervention 3: Control: Canola oil. Yes - There is a plan to make this available What will be shared: baseline and after treatment data values of primary and secondary outcome variables will be available for researchers. When: Data will be available after the summary data become published. To whom: The data will be available for all researchers interested in the subject. Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Mojgan Amiri
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 mojgan.amiri2015@yahoo.com Nutrition and Food security Research Center, Faculty of Health, Shahid Sadoughi University of Medica scientific Amin Salehi-Abargouei
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 abargouei@gmail.com Nutrition and Food security Research Center, Faculty of Health, Shahid Sadoughi University of Medica Iran (Islamic Republic of) 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 18 years 60 years Both 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 E11 Non-insulin-dependent diabetes mellitus Lifestyle Lifestyle Lifestyle Intervention: Sesame-canola oli control: sesame oil Control: Canola oil 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. Serum fasting blood sugar(FBS). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. 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. Serum Total cholesterol. Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Serum triglyceride level (TG). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. BMI(body mass index). Timepoint: entrance and start and the end of each intervention period. Method of measurement: kg/m2. Body Fat percent. Timepoint: entrance and start and the end of each intervention period. Method of measurement: by body composition analyzer. Muscle mass percent. Timepoint: entrance and start and the end of each intervention period. Method of measurement: by body composition analyzer. Weight. Timepoint: entrance and start and the end of each intervention period. Method of measurement: by body Calibrated scale. Blood pressure. Timepoint: entrance and start and the end of each intervention period. Method of measurement: by Barometer. Insulin. Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate ELISA kit. Lipoprotein(a). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Apo lipoprotein A (Apo A). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Apo lipoprotein B(Apo B). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Alkaline phosphatase ( ALP). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Alanine aminotransferase (ALT). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Aspartate aminotransferase (AST). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Gama glutamil transferase (GGT). Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Urea. Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Creatinine. Timepoint: start and the end of each intervention period. Method of measurement: using Appropriate kits, by Alpha-Classic autoanalyzer. Neshatavar food industry (Datis) Vice Chancellor for Research, shahid sadughi yazd University of Medical Sciences Neshatavar food industry (Datis) Approved 2016-05-29 Ethics committe of Shahid Sadoughi University of Medical Sciences Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran Yazd Yazd Iran (Islamic Republic of) Approved 2016-05-29 Ethics committe of Shahid Sadoughi University of Medical Sciences Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)