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IRCT20250505065611N1 IRCT 2025-07-06 Tehran University The Effect of Physical Activity and Caloric Restriction on Inflammatory Markers and Blood Glucose in Overweight and Obese Women The Effects of Different Doses of Combined Exercise Training with Caloric Restriction on Levels of Endocan and Interleukin-6 in Overweight and Obese Sedentary Women 2025-05-18 anticipated 40 Complete https://irct.ir/trial/83430 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Overweight and obesity. Intervention 1: Intervention Group 1: Two exercise sessions per week + caloric restriction (a daily deficit of 360 kcal). In addition, each exercise session will involve an energy expenditure of approximately 500 kcal. Participants in this group will engage in designated exercise two days a week, consuming 500 calories per exercise session, and the diet set for these individuals will be 360 ​​calories less than their usual daily intake, so that the total calorie intake through diet and two sessions of exercise per week will be equivalent to 3,500 calories per week. A total of 8 weeks have been planned for this intervention. Exercise activity in each session includes warm-up and aerobic activity (treadmill) and resistance activity (chest press, lat pull-ups, military press, leg extension, leg press, crunches) and cool-down. The intensity of the exercises increases from 60% of one repetition maximum in the first week to 80% of one repetition maximum in the eighth week. Intervention 2: Intervention Group 2: Three exercise sessions per week + caloric restriction (a daily deficit of 285kcal). In addition, each exercise session will involve an energy expenditure of approximately 500 kcal. Participants in this group will engage in designated exercise three days a week, consuming 500 calories per exercise session, and the diet set for these individuals will be 285 ​​calories less than their usual daily intake, so that the total calorie intake through diet and three sessions of exercise per week will be equivalent to 3,500 calories per week. A total of 8 weeks have been planned for this intervention. Exercise activity in each session includes warm-up and aerobic activity (treadmill) and resistance activity (chest press, lat pull-ups, military press, leg extension, leg press, crunches) and cool-down. The intensity of the exercises increases from 60% of one repetition maximum in the first week to 80% of one repetition maximum in the eighth week. Intervention 3: Intervention Group 3: Four exercise sessions per week + caloric restriction (a daily deficit of 215kcal). In addition, each exercise session will involve an energy expenditure of approximately 500 kcal. Participants in this group will engage in designated exercise four days a week, consuming 500 calories per exercise session, and the diet set for these individuals will be 215 ​​calories less than their usual daily intake, so that the total calorie intake through diet and four sessions of exercise per week will be equivalent to 3,500 calories per week. A total of 8 weeks have been planned for this intervention. Exercise activity in each session includes warm-up and aerobic activity (treadmill) and resistance activity (chest press, lat pull-ups, military press, leg extension, leg press, crunches) and cool-down. The intensity of the exercises increases from 60% of one repetition maximum in the first week to 80% of one repetition maximum in the eighth week. Intervention 4: Control Group: Caloric restriction only (a daily dietary caloric deficit of 500 kcal). Participants in this group do not participate in any exercise activities and the diet adjusted for these people will be 500 calories less than their usual daily intake, so that the total calorie restriction through the diet is equivalent to 3500 calories per week. A total of 8 weeks are planned to conduct this intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available
public Katayoun Zamani
No. 26, Morvarid Baharestan Tower, Kermanshah St., West Hamedan, Iran
Tehran Iran (Islamic Republic of) 1497973590 +98 21 4612 3722 Katayoun.zamani@ut.ac.ir Tehran University scientific Katayoun Zamani
No. 26, Morvarid Baharestan Tower, Kermanshah St., West Hamedan, Iran
Tehran Iran (Islamic Republic of) 1497973590 +98 21 4612 3722 Katayoun.zamani@ut.ac.ir Tehran University Iran (Islamic Republic of) Body Mass Index (BMI) between 27 and 35 No use of specific medications No underlying diseases such as diabetes 19 years 50 years Female Physical problems that prevent engagement in physical activity Under medical treatment or following a specific diet E66 Overweight and obesity Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention Group 1: Two exercise sessions per week + caloric restriction (a daily deficit of 360 kcal). In addition, each exercise session will involve an energy expenditure of approximately 500 kcal. Participants in this group will engage in designated exercise two days a week, consuming 500 calories per exercise session, and the diet set for these individuals will be 360 ​​calories less than their usual daily intake, so that the total calorie intake through diet and two sessions of exercise per week will be equivalent to 3,500 calories per week. A total of 8 weeks have been planned for this intervention. Exercise activity in each session includes warm-up and aerobic activity (treadmill) and resistance activity (chest press, lat pull-ups, military press, leg extension, leg press, crunches) and cool-down. The intensity of the exercises increases from 60% of one repetition maximum in the first week to 80% of one repetition maximum in the eighth week. Intervention Group 2: Three exercise sessions per week + caloric restriction (a daily deficit of 285kcal). In addition, each exercise session will involve an energy expenditure of approximately 500 kcal. Participants in this group will engage in designated exercise three days a week, consuming 500 calories per exercise session, and the diet set for these individuals will be 285 ​​calories less than their usual daily intake, so that the total calorie intake through diet and three sessions of exercise per week will be equivalent to 3,500 calories per week. A total of 8 weeks have been planned for this intervention. Exercise activity in each session includes warm-up and aerobic activity (treadmill) and resistance activity (chest press, lat pull-ups, military press, leg extension, leg press, crunches) and cool-down. The intensity of the exercises increases from 60% of one repetition maximum in the first week to 80% of one repetition maximum in the eighth week. Intervention Group 3: Four exercise sessions per week + caloric restriction (a daily deficit of 215kcal). In addition, each exercise session will involve an energy expenditure of approximately 500 kcal. Participants in this group will engage in designated exercise four days a week, consuming 500 calories per exercise session, and the diet set for these individuals will be 215 ​​calories less than their usual daily intake, so that the total calorie intake through diet and four sessions of exercise per week will be equivalent to 3,500 calories per week. A total of 8 weeks have been planned for this intervention. Exercise activity in each session includes warm-up and aerobic activity (treadmill) and resistance activity (chest press, lat pull-ups, military press, leg extension, leg press, crunches) and cool-down. The intensity of the exercises increases from 60% of one repetition maximum in the first week to 80% of one repetition maximum in the eighth week. Control Group: Caloric restriction only (a daily dietary caloric deficit of 500 kcal). Participants in this group do not participate in any exercise activities and the diet adjusted for these people will be 500 calories less than their usual daily intake, so that the total calorie restriction through the diet is equivalent to 3500 calories per week. A total of 8 weeks are planned to conduct this intervention. Endocan. Timepoint: Endocan levels are measured through blood tests one week before the intervention begins and 60 days after the intervention period ends. Method of measurement: Endocan levels are measured through blood tests using ELISA kits. Interleukin-6. Timepoint: Interleukin-6 levels are measured through blood tests one week before the intervention begins and 60 days after the intervention period ends. Method of measurement: Interleukin-6 levels are measured through blood tests using ELISA kits. Weight. Timepoint: Weight measurement is at the beginning of the study (before the start of the intervention) and 60 days after the start of the intervention. Method of measurement: A scale is used to measure weight. Body Fat Percentage. Timepoint: Body Fat Percentage is at the beginning of the study (before the start of the intervention) and 60 days after the start of the intervention. Method of measurement: Body fat percentage will be measured using a body composition analyzer (InBody 270). Muscle mass. Timepoint: Muscle mass is at the beginning of the study (before the start of the intervention) and 60 days after the start of the intervention. Method of measurement: Muscles mass will be measured using a body composition analyzer (InBody 270). Visceral Fat Levels. Timepoint: Visceral Fat Levels is at the beginning of the study (before the start of the intervention) and 60 days after the start of the intervention. Method of measurement: Visceral Fat Levels will be measured using a body composition analyzer (InBody 270). Tehran University Approved 2025-05-03 Research Ethics Committees of Tehran University - Faculty of Sport Sciences and Health Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)