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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

Protocol summary

Study aim
Determine 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
Design
-A 12-week double-blind, randomized parallel clinical trial on 60 overweight and obese adolescents
Settings and conduct
This study is a double-blind clinical trial that will be performed to determine the effect of Chitosan supplementation on intestinal microbiome, appetite regulating hormones, anthropometric factors, lipid profile and carbohydrate metabolism in overweight and obese adolescents. After the approval of the proposal in the ethics committee of IUMS, adolescents who refer to the Obesity Clinic of Mofid Hospital will be invited to participate in the study. Eligible individuals will be interviewed in person and the goals, methods and importance of conducting the study will be explained in detail to each of them and their parents. They will be divided into 2 groups (placebo group, Chitosan group) and they are asked to take 3 grams of supplement or placebo daily, half an hour before lunch with 1 glass of water.
Participants/Inclusion and exclusion criteria
Girls and boys 10 to 18 years old with a Z score of body mass index higher than 1 and less than 3 for age and sex who do not have cardiovascular disease, type 1 or 2 diabetes, liver disease, gastrointestinal (celiac, IBD or IBS) or Kidney with all metabolic disorders including PKU, MSUD, urea cycle disorders).They also do not have a history of gastrointestinal surgery, taking medications or supplements that affect appetite, weight or metabolism, and have not followed any weight loss diet or heavy exercise program in the past 6 months.
Intervention groups
-3 grams of Chitosan powder daily for 30 minutes to 1 hour before lunch for 12 weeks
Main outcome variables
Weight, BMI z score, waist circumference and NPY level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091114002709N57
Registration date: 2021-06-20, 1400/03/30
Registration timing: registered_while_recruiting

Last update: 2021-06-20, 1400/03/30
Update count: 0
Registration date
2021-06-20, 1400/03/30
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2021-10-21, 1400/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 10 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
This study will be double-blindness, so that researchers and all participants are unaware of intervention and control groups.
Placebo
Used
Assignment
Parallel
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.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Iran University of Medical Sciences
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.IUMS.REC.1400.104

Health conditions studied

1

Description of health condition studied
Obese or overweight adolescents
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Weight
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Seca scale

2

Description
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)

3

Description
Waist circumference
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Measuring tape

4

Description
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 outcomes

1

Description
Stool microbiome
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
DNA extraction kit

2

Description
BMI z score
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Calculation

3

Description
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

4

Description
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

5

Description
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

6

Description
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

7

Description
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

8

Description
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

Intervention groups

1

Description
Intervention group: 3 grams of chitosan powder daily for 30 minutes to 1 hour before lunch for 12 weeks
Category
Treatment - Other

2

Description
Control group: 3 g of maltodextrin daily 30 minutes to 1 hour before lunch for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid Hospital
Full name of responsible person
Aliakbar Sayyari
Street address
No. 1057, Mofid Children's Hospital, above Hosseinieh Ershad, Shariati St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sayyed Abbas Motevallian, deputy head of Research and technology, Iran university of medical sci
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14496145535
Phone
+98 21 8860 7945
Email
shidfar.f@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 7945
Email
shidfar.f@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 7945
Email
shidfar.f@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main implications can be shared at the end of the study.
When the data will become available and for how long
The access period will be 6 months after the results are published.
To whom data/document is available
The data from this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
6 months after the publication of the articles obtained from the data of this project, at the request of the person in charge of the project and his consent, the study data can be made available to researchers.
From where data/document is obtainable
Applicants can contact the responsible author via email or the following mailing address to obtain the required data. Postal address: Tehran-Hemmat Highway-Iran University of Medical Sciences-Faculty of Health-Department of Nutrition. Contact number: 00982188622755. Email: shidfar.f@iums.ac.ir
What processes are involved for a request to access data/document
Applicants will be able to access the study data by sending an email to the responsible author within a maximum of one week.
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