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IRCT20091114002709N57 IRCT 2021-06-20 Iran University of Medical Sciences The effect of chitosan supplementation on some appetite regulating hormones, intestinal microbiota, anthropometric indices and blood sugar and lipid control indices in overweight and obese adolescents The effect of chitosan supplementation on some appetite regulating hormones, intestinal microbiota, anthropometric indices and blood sugar and lipid control indices in overweight and obese adolescents 2021-05-21 anticipated 60 Complete https://irct.ir/trial/55740 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In order to apply concealment in the randomization process, individual codes will be used on the medicine boxes and the desired code will also be produced by the software, Randomization description: Randomization will be done by the restricted randomization method: first people in terms of age and sex in quadratic blocks (A, B, C and D) will be placed. Then, random allocation of people in each block to intervention and control groups will be done. random allocation of individuals to intervention and control groups, will be performed by means of software, Blinding description: This study will be double-blindness, so that researchers and all participants are unaware of intervention and control groups. 3 Obese or overweight adolescents. Intervention 1: Intervention group: 3 grams of chitosan powder daily for 30 minutes to 1 hour before lunch for 12 weeks. Intervention 2: Control group: 3 g of maltodextrin daily 30 minutes to 1 hour before lunch for 12 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 Dr.Farzad Shidfar
Hemmat Highway, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 14496145535 +98 21 8860 7945 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Dr.Farzad Shidfar
Hemmat Highway, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8860 7945 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate Overweight and obese girls and boys 10 to 18 years old with Z score body mass index higher than 1 and less than 3 for age and sex 10 years 18 years Both Use of probiotic or prebiotic or synbiotic supplements for the past three months or any foods fortified with these supplements • Take any antibiotics 3 months before the study • Have type 1 or 2 diabetes, cardiovascular disease or hepatic, gastrointestinal (Celiac, IBD or IBS) or renal disorders or all metabolic disorders including PKU, MSUD, urea cycle disorders or .. • History of gastrointestinal surgery • Taking drugs or supplements that affect appetite, weight or metabolism at least three months before the study (such as medications that affect carbohydrate, protein or fat metabolism, and medications that reduce or increase appetite or food intake, including herbal supplements) • Have any weight loss diet or any program heavy exercise in the last 6 months • Pregnancy and lactation • Smoking (more than one cigarette per week or more than 200 cigarettes in a lifetime) • Having any allergies to chitosan or shrimp • Exclusion criteria: • 1- Having any acute illness • 2- Occurrence of any accident that affects a person's health • 3- Taking antibiotics while studying • 4- Low acceptance rate more than 80% • 5- Not following the intervention • 6- Immigration • 7- Leaving the study based on the personal desire of the participants or their parents E66 Overweight and obesity Treatment - Other Placebo Intervention group: 3 grams of chitosan powder daily for 30 minutes to 1 hour before lunch for 12 weeks Control group: 3 g of maltodextrin daily 30 minutes to 1 hour before lunch for 12 weeks Weight. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Seca scale. Body mass index(BMI). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Weight (kg) divided by height squared (square meters). Waist circumference. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Measuring tape. Serum of Neuropeptide Y (NPY). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Blood sampling and measurement by ELISA method. Stool microbiome. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: DNA extraction kit. BMI z score. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Calculation. Serum leptin. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Blood sampling and measurement by ELISA method. Serum adibonectin. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Blood sampling and measurement by ELISA method. Serum cholesterol, triglyceride, LDL and HDL levels. Timepoint: At the beginning of the study and at the end of week 12. 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 12. 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 12. Method of measurement: Blood sampling and measurement by ELISA method. Serum HOMA-IR. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: Blood sampling and measurement by ELISA method. Iran University of Medical Sciences Approved 2021-04-20 Ethic Committee of Iran University of Medical Sciences Hemmat Highway, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)