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IRCT20160702028742N7 IRCT 2020-03-19 Shahid Beheshti University of Medical Sciences Effects of Intermittent Calorie Restriction on Inflammatory Markers Effects of Intermittent Calorie Restriction on Inflammatory Markers in Overweight and Obese Adults 2019-04-12 anticipated 80 Complete https://irct.ir/trial/46388 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization tool is a sealed envelope. Stratified block randomization will be employed to assign subjects to each of the two groups. Stratification subdivides patients into those with diabetes or without diabetes and in each stratum, blocks of size 4 (two intervention and two control) will be defined and then the patients within each block will be assigned to intervention receiving intermittent calorie-restriction diet (intervention group) or continuous calorie restriction diet (comparison group). N/A Condition 1: Overweight and obesity. Condition 2: overweight and obesity. Intervention 1: Intervention group: Participants in the group will be on a very low-calorie diet (30% of the individual's energy requirement for weight maintenance) for 3 days throughout the week, and on other days they will have the calorie needed to maintain weight (100% of their daily need for energy). Intervention 2: Control group: Participants in this group will have a daily calorie restricted diet (calorie deficient equivalent to a 30% of one's energy requirement for weight maintenance). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Mahsa Maroofi
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
Tehran Iran (Islamic Republic of) 1981619573 009822934770 Mahwoon3424@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr Javad Nasrollahzadeh
No. 46, Hafezi street, Farahzadi blvd, Qods Town, Tehran
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7424 jnasrollahzadeh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Body Mass Index over than 25 kg/m2 Willing to participate in the study Age between 18 to 60 years non smoker haven't been under any diet at least 3 months before participating in the study not starting any new exercise program or changing the previous exercise while in the study 18 years 60 years Both chronic kidney disease stage 3-5 consuming Insulin or Insulin-inducing drugs. consuming omega 3 supplement a history of cholecystitis Heart arrhythmia Overweight and obesity Overweight and obesity Treatment - Other Treatment - Other Intervention group: Participants in the group will be on a very low-calorie diet (30% of the individual's energy requirement for weight maintenance) for 3 days throughout the week, and on other days they will have the calorie needed to maintain weight (100% of their daily need for energy). Control group: Participants in this group will have a daily calorie restricted diet (calorie deficient equivalent to a 30% of one's energy requirement for weight maintenance). Plasma C-reactive protein (CRP). Timepoint: Baseline and the end of the study. Method of measurement: Turbidometric method using kits. Interleukin 6. Timepoint: Baseline and the end of the study. Method of measurement: ELISA. Interleukin 10. Timepoint: Baseline and the end of the study. Method of measurement: ELISA. Shahid Beheshti University of Medical Sciences Approved 2019-06-19 Ethics Committee of Shahid Beheshti University of Medical Sciences No. 46, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)