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IRCT20220727055563N1 IRCT 2022-08-19 Shahid Beheshti University of Medical Sciences Effects of N-Acetylcysteine on senescence of visceral adipose tissue, anthropometric indices, serum levels of lipid profile, glycemic indices, and inflammatory factors in obese adults Effects of N-Acetylcysteine on senescence of visceral adipose tissue, anthropometric indices, serum levels of lipid profile, glycemic indices, and inflammatory factors in obese adults 2022-08-11 anticipated 50 Complete https://irct.ir/trial/65003 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be used as Stratified Randomization using the Permuted block randomization method with quadruple and double blocks. According to the sample size of 70 that has been determined, the quadruple and double blocks will be produced using the software. In the Stratified Randomization method, age and BMI will be used as layers. In order to apply concealment in the randomization process, unique codes will be used on medicine boxes, and the desired code will be generated by the software. As each person enters the study based on the generated sequence, the drug package in which the desired code is recorded will be assigned to the person, and therefore, before choosing the person, no one will be aware of the type of treatment that the person will receive. Also, the random sequence generated during the study will be immune to prediction, Blinding description: The study is double-blind. Participants will be divided into two groups receiving N-Acetylcysteine supplementation and the placebo group. Due to the double-blindness of the study, before starting the study, sets of cans containing N-Acetylcysteine supplementation will be prepared by someone other than the researcher, and the placebo will be similar in appearance to N-Acetylcysteine, so that the researcher does not know the type of treatment received by each group. In addition, the researcher in the evaluation phase of the desired outcomes (anthropometric measurements, blood tests, and biochemistry) from the allocation of participants in each of the groups (intervention and control group) until after the end of the intervention period will be uninformed. 3 Obesity adults. Intervention 1: Intervention group: Daily 600 mg of NAC supplement prepared by Osvah Pharmaceutical Company of Iran for 4 weeks. Intervention 2: Control group: Daily 600 mg maltodextrin supplement prepared by Karen Pharmaceutical Company of Iran for 4 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hamid Zand
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2235 7483 hamidzand@gmail.com Shahid Beheshti University of Medical Sciences scientific Hamid Zand
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2235 7483 hamidzand@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Obese people with a body mass index greater than or equal to 30 kg/m2. Age over 25 years Non-pregnant Non-lactating Not suffering from chronic and acute inflammatory, and infectious diseases Not suffering from high blood pressure and vascular diseases Not receiving alcohol and smoking 25 years no limit Both Receiving weight loss and antioxidant drugs and supplements in the last three months Participating in other clinical trial studies at the same time as the present study. Adherence to weight loss diets during the last three months. History of gastrointestinal or bariatric surgeries. E66.0 Obesity due to excess calories Treatment - Drugs Placebo Intervention group: Daily 600 mg of NAC supplement prepared by Osvah Pharmaceutical Company of Iran for 4 weeks Control group: Daily 600 mg maltodextrin supplement prepared by Karen Pharmaceutical Company of Iran for 4 weeks Weight. Timepoint: At the beginning of the study and at the end of week 4. Method of measurement: Seca scale. Beta-galactosidase activity. Timepoint: The end of week 4. Method of measurement: Using PCR (polymerase chain reaction). Waist circumference. Timepoint: At the beginning of the study and at the end of week 4. Method of measurement: Measuring tape. Serum cholesterol, triglyceride, LDL and HDL levels. Timepoint: At the beginning of the study and at the end of week 4. Method of measurement: Blood sampling and measurement by ELISA method. Serum glucose levels. Timepoint: At the beginning of the study and at the end of week 4. Method of measurement: Blood sampling and measurement by ELISA method. Serum insulin levels. Timepoint: At the beginning of the study and at the end of week 4. Method of measurement: Blood sampling and measurement by ELISA method. C-reactive protein (CRP) level. Timepoint: At the beginning of the study and at the end of week 4. Method of measurement: Blood sampling and measurement by ELISA method. Body mass index. Timepoint: At the beginning of the study and at the end of week 4. Method of measurement: Calculation. Interleukin-6. Timepoint: At the beginning of the study and at the end of week 4. Method of measurement: Blood sampling and measurement by ELISA method. Shahid Beheshti University of Medical Sciences Approved 2022-05-31 Research Ethics Committees of National Nutrition & Food Technology Research Institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)