Obese or overweight adolescents. Overweight and obesity
Conditions
Interventions
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 b
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Farzad Shidfar
Iran University of Medical Sciences
Outcome results
None listed