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IRCT20260123068640N1 IRCT 2026-03-16 Tehran University Effect of physical exercise and caloric restriction on the inflammatory processes and pathogenesis of the cardiovascular system Effect of exercise volume and caloric restriction on the ADMA and LOX-1 levels in obese and overweight sedentary women 2026-04-20 anticipated 40 Complete https://irct.ir/trial/89270 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A unique ordinal number will be allocated to each volunteer (starting at 1). The web-based research randomizer software (https://www.randomizer.org) will then be used to randomly select and assign 40 participants to four equal groups of 10. The input values ​​in this software are the number of sets (group = 4), the number of numbers in each set (each group = 10), and the range of numbers (1 to the number of volunteers), Blinding description: 1. Participants will not be informed regarding the type of interventions/groups and will only be given a general explanation of the study. 2. The exercise and diet design specialist will not be informed about the outcome variables. 3. The exercise instructor will not be informed about the outcome variables. 4. The outcomes examiner/assessor at pre-test and post-test will not be informed regarding intervention/group type and the participants’ belonging to a given intervention/group. 5. The statistical analyst will not be informed of the type of interventions/groups. N/A Overweight and Obesity. Intervention 1: First intervention group: Exercise volume 1 (16 sessions in eight weeks, two sessions per week, calorie consumption per session 500 calories) + caloric restriction 1 (caloric restriction per day 360 calories). The physical exercise program will include a general warm-up (for five minutes), aerobic exercise (running on a treadmill for 25-35 minutes at 65-75% of maximum heart rate), resistance exercises (chest press, Lat pull-down, military press, leg extension, leg press, and crunches for 25-45 minutes at 60-80% of one maximum repetition) and cool-down (for five minutes). The intensity of physical exercises will gradually increase on a weekly basis over the course of eight weeks. The total calories deducted through physical exercise and the calorie restriction will be approximately 3,500 calories per week. Intervention 2: Second intervention group: Exercise volume 2 (24 sessions in eight weeks, three sessions per week, calorie consumption per session 500 calories) + caloric restriction 2 (caloric restriction per day 285 calories). The physical exercise program will include a general warm-up (for five minutes), aerobic exercise (running on a treadmill for 25-35 minutes at 65-75% of maximum heart rate), resistance exercises (chest press, Lat pull-down, military press, leg extension, leg press, and crunches for 25-45 minutes at 60-80% of one maximum repetition) and cool-down (for five minutes). The intensity of physical exercises will gradually increase on a weekly basis over the course of eight weeks. The total calories deducted through physical exercise and the calorie restriction will be approximately 3,500 calories per week. Intervention 3: Third intervention group: Exercise volume 3 (32 sessions in eight weeks, four sessions per week, calorie consumption per session 500 calories) + caloric restriction 2 (caloric restriction per day 215 calories). The physical exercise program will include a general warm-up (for five minutes), aerobic exercise (running on a treadmill for 25-35 minutes at 65-75% of maximum heart rate), resistance exercises (chest press, Lat pull-down, military press, leg extension, leg press, and crunches for 25-45 minutes at 60-80% of one maximum repetition) and cool-down (for five minutes). The intensity of physical exercises will gradually increase on a weekly basis over the course of eight weeks. The total calories deducted through physical exercise and the calorie restriction will be approximately 3,500 calories per week. Intervention 4: Control group: Only caloric restriction (caloric restriction for eight weeks per day 500 calories). The total calories deducted through the caloric restriction will be approximately 3,500 calories per week. Yes - There is a plan to make this available What will be shared: All data will be available without mentioning the names of the participants. When: After Juanary 2027 To whom: Students and researchers employed in academic and scientific institutions Conditions: The data and documents from this study will be available for research and rehabilitation purposes. Where to obtain: All requests must be sent to the E-mail resposible for public responsiveness at hatami.hosna@ut.ac.ir. How to obtain: 1. Send the request mentioning the required documents and the purposes of its use by applicant 2. Review by the research team 3. Send the documents to the applicant Comments:
public Hosna Hatami
Faculty of Sport Sciences and Health, Between 15th and 16 Ave., Northern Kargar St.
Tehran Iran (Islamic Republic of) ۱۴۱۷۹۳۵۸۴۰ +98 21 8835 1730 hatami.hosna@ut.ac.ir Tehran University scientific Hosna Hatami
Faculty of Sport Sciences and Health, Between 15th and 16 Ave., Northern Kargar St.
Tehran Iran (Islamic Republic of) ۱۴۱۷۹۳۵۸۴۰ +98 21 8835 1730 hatami.hosna@ut.ac.ir Tehran University Iran (Islamic Republic of) Body mass index between 27 and 35 kg/m2 No underlying (e.g., diabetes), cardiovascular, or musculoskeletal diseases Lack of pregnancy or breastfeeding No-use of specific medication 19 years 40 years Female Having physical injury/problem restricting physical exercise Being under treatment or following a special diet E66 Overweight and Obesity Rehabilitation Rehabilitation Rehabilitation Rehabilitation First intervention group: Exercise volume 1 (16 sessions in eight weeks, two sessions per week, calorie consumption per session 500 calories) + caloric restriction 1 (caloric restriction per day 360 calories). The physical exercise program will include a general warm-up (for five minutes), aerobic exercise (running on a treadmill for 25-35 minutes at 65-75% of maximum heart rate), resistance exercises (chest press, Lat pull-down, military press, leg extension, leg press, and crunches for 25-45 minutes at 60-80% of one maximum repetition) and cool-down (for five minutes). The intensity of physical exercises will gradually increase on a weekly basis over the course of eight weeks. The total calories deducted through physical exercise and the calorie restriction will be approximately 3,500 calories per week. Second intervention group: Exercise volume 2 (24 sessions in eight weeks, three sessions per week, calorie consumption per session 500 calories) + caloric restriction 2 (caloric restriction per day 285 calories). The physical exercise program will include a general warm-up (for five minutes), aerobic exercise (running on a treadmill for 25-35 minutes at 65-75% of maximum heart rate), resistance exercises (chest press, Lat pull-down, military press, leg extension, leg press, and crunches for 25-45 minutes at 60-80% of one maximum repetition) and cool-down (for five minutes). The intensity of physical exercises will gradually increase on a weekly basis over the course of eight weeks. The total calories deducted through physical exercise and the calorie restriction will be approximately 3,500 calories per week. Third intervention group: Exercise volume 3 (32 sessions in eight weeks, four sessions per week, calorie consumption per session 500 calories) + caloric restriction 2 (caloric restriction per day 215 calories). The physical exercise program will include a general warm-up (for five minutes), aerobic exercise (running on a treadmill for 25-35 minutes at 65-75% of maximum heart rate), resistance exercises (chest press, Lat pull-down, military press, leg extension, leg press, and crunches for 25-45 minutes at 60-80% of one maximum repetition) and cool-down (for five minutes). The intensity of physical exercises will gradually increase on a weekly basis over the course of eight weeks. The total calories deducted through physical exercise and the calorie restriction will be approximately 3,500 calories per week. Control group: Only caloric restriction (caloric restriction for eight weeks per day 500 calories). The total calories deducted through the caloric restriction will be approximately 3,500 calories per week. Concentration of Asymmetric Dimethylarginine (ADMA) in blood serum. Timepoint: Immediately before and after 8-week intervention. Method of measurement: ELISA kit based on the laboratory protocols. Concentration of Lectin-like Oxidized Low-density Lipoprotein Receptor-1 (LOX-1) in blood serum. Timepoint: Immediately before and after 8-week intervention. Method of measurement: ELISA kit based on the laboratory protocols. Body mass index based on the formula (weight in kilograms divided by square of height in meters). Timepoint: Immediately before and after 8-week intervention. Method of measurement: Weighing scale and stadiometer (SECA, Germany). Body composition (muscle mass, fat mass, visceral fat mass, waist-to-hip ratio). Timepoint: Immediately before and after 8-week intervention. Method of measurement: Body composition analyzer device (InBody 270). Blood lipid profile using colorimetric assay. Timepoint: Immediately before and after 8-week intervention. Method of measurement: Colorimetric assay based on the laboratory protocols. Tehran University Approved 2025-05-10 Research Ethics Committees of Tehran University - Faculty of Sport Sciences and Health Faculty of Sport Sciences and Health, Between 15th and 16 Ave., Northern Kargar St. Tehran Tehran Iran (Islamic Republic of)