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

Phase 3

Recruiting

• Conditions: Obese or overweight adolescents.; Overweight and obesity

• Registration Number: IRCT20091114002709N57
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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 • • 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.