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IRCT20210617051606N2 IRCT 2021-09-13 Razi University The effect of exercise training and Camelina oil consumption on type 2 diabetes The effect of 8 weeks of combined home-based exercise and Camelina oil consumption on insulin resistance, lipid profile, quality of life and some psychological indices in women with type 2 diabetes 2021-06-22 anticipated 48 Complete https://irct.ir/trial/58573 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, permuted block randomization via the www.randomization.com website will be used. To do so, first, a unique number will be allocated to each subject as the identifier code and, a 48-digit sequence (equal to sample size) will be created. Then, treatment labels including 1) exercise + Camelina group; 2) Exercise group; 3) Camelina group, and 4) control group will be entered in the relevant section on the website. After defining the treatment groups and to avoid potential problems associated with equal block sizes, permuted block randomization with differents block sizes will be applied. In this case, by knowing the sample size, the block sizes will be unequal and a multiple of the number of treatment groups (for example, block sizes of 2, 4, 6, or 8). The website has the ability to randomly specify the sequence of blocks with different sizes. In the final step and upon performing the 'Generate Plan' on the website, all subjects will be randomly assigned to blocks of different sizes that already have a random sequence. Finally, the group (treatment) of each subject will be specified by the use of the identifier code and checking out the blocks. N/A Type 2 Diabetes. Intervention 1: Intervention group (Exercise + Camelina): this group performs combined home-based aerobic and bodyweight resistance training 3 times a week for 8 weeks. The intensity of aerobic and resistance training will be controlled by the use of a 6-20 Borg scale. In the first week, the training intensity will be 11 and, in week 8, the intensity will be 13 on the Borg scale. The aerobic training is in category A according to American College of Sports Medicine (ACSM) guidelines that require minimum skill and physical fitness. The resistance training includes Squat, Lunges, and Push-up by the use of body weight. This group also consumes 27 grams of Camelina oil per day with meals for 8 weeks. This oil is transparent yellow in color and has no unusual taste and smell. Camelina oil has a standard document proved by Iran National Standards Organization. Intervention 2: Intervention group 2 (Exercise): this group performs combined home-based aerobic and bodyweight resistance training 3 times a week for 8 weeks. The intensity of aerobic and resistance training will be controlled by the use of a 6-20 Borg scale. In the first week, the training intensity will be 11 and, in week 8, the intensity will be 13 on the Borg scale. The aerobic training is in category A according to American College of Sports Medicine (ACSM) guidelines that require minimum skill and physical fitness. The resistance training includes Squat, Lunges, and Push-up by the use of body weight. Intervention 3: Intervention group 3 (Camelina): This group consumes 27 grams of Camelina oil per day with meals for 8 weeks. This oil is transparent yellow in color and has no unusual taste and smell. Camelina oil has a standard document proved by Iran National Standards Organization. Intervention 4: Control group: this group has the the normal life during the study. Yes - There is a plan to make this available What will be shared: All data are shared after the de-identification of the participants When: 3 months after publication To whom: All individuals upon formal request Conditions: Data sharing requests are accepted for any purposes Where to obtain: To obtain any data/document, please send an e-mail to Ehsan Amiri, a faculty member at Razi University, through the following e-mail address: e.amiri@razi.ac.ir How to obtain: Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail Comments:
public Ehsan Amiri
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir Razi University scientific Ehsan Amiri
Room 73. Faculty of Sport Sciences, Razi University, University St, Taq-e-Bostan, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 7609 e.amiri@razi.ac.ir Razi University Iran (Islamic Republic of) Not participation in regular exercise training over the last 6 months Having type 2 diabetes confirmed by specialist Fasting blood glucose of equal or more than 126 milligrams in deciliter to 400 milligrams in deciliter No insulin injection Getting the certification of no prohibition of participating in exercise training program from a specialist 20 years 50 years Female Acute or chronic inflammatory diseases Heart diseases Pregnancy Alcohol and other kinds of drug addiction Musculoskeletal disorder Refusal to give informed consent E08 Diabetes mellitus due to underlying condition Other Other Other Other Intervention group (Exercise + Camelina): this group performs combined home-based aerobic and bodyweight resistance training 3 times a week for 8 weeks. The intensity of aerobic and resistance training will be controlled by the use of a 6-20 Borg scale. In the first week, the training intensity will be 11 and, in week 8, the intensity will be 13 on the Borg scale. The aerobic training is in category A according to American College of Sports Medicine (ACSM) guidelines that require minimum skill and physical fitness. The resistance training includes Squat, Lunges, and Push-up by the use of body weight. This group also consumes 27 grams of Camelina oil per day with meals for 8 weeks. This oil is transparent yellow in color and has no unusual taste and smell. Camelina oil has a standard document proved by Iran National Standards Organization. Intervention group 2 (Exercise): this group performs combined home-based aerobic and bodyweight resistance training 3 times a week for 8 weeks. The intensity of aerobic and resistance training will be controlled by the use of a 6-20 Borg scale. In the first week, the training intensity will be 11 and, in week 8, the intensity will be 13 on the Borg scale. The aerobic training is in category A according to American College of Sports Medicine (ACSM) guidelines that require minimum skill and physical fitness. The resistance training includes Squat, Lunges, and Push-up by the use of body weight. Intervention group 3 (Camelina): This group consumes 27 grams of Camelina oil per day with meals for 8 weeks. This oil is transparent yellow in color and has no unusual taste and smell. Camelina oil has a standard document proved by Iran National Standards Organization. Control group: this group has the the normal life during the study Changes in insulin resistance. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: By blood sample and Hemostatic Model Assessment for Insulin Resistance (HOMA-IR). In this case, fasting blood insulin and glucose are measured and then, they will be put in the HOMA-IR formula. Changes in fasting blood glucose. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: By blood sample in fasting condition. Changes in lipid profile. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: By blood sample in fasting condition. Change in quality of life. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: World health organization standard quality of life questionnaire (short version). Change in depression severity. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: Hamilton Depression Rating Scale. Change in physical self-concept. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Physical self-concept questionnaire. Change in the quality of sleep. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Pittsburgh Sleep Quality Index. Change in anxiety. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Beck Anxiety Inventory. Change in self-esteem. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Rosenberg’s Self-Esteem Scale. Razi University Approved 2021-06-23 Research Ethics Committees of Kermanshah Razi University Deputy of Research and Technology, Razi University, University Str, Taq-e-bostan, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)