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Effect of Eight Weeks of two types of High-Intensity Interval Training on Appetite sensation, Appetite-related Hormones and Body Composition in Overweight and Obese Men

Protocol summary

Study aim
Effect of Eight Weeks of two types of High-Intensity Interval Training on Appetite sensation, Appetite-related Hormones and Body Composition in Overweight and Obese Men
Design
The present study is a randomized, 3 parallel-group trial without blinded outcome
Settings and conduct
In a semi-experimental research project, among volunteer overweight and obese men (BMI > 25) at Tabriz University, with an age range of 20–30 years and no regular training in the past two years, 30 people will be randomly selected. After completion of the informed consent form, they will be randomly assigned into 3 groups of 10, including the high-intensity interval training group, the high-intensity interval functional training group, and the control group. On the first day, weight, height, BMI, and fat percentage will be measured by BIA, as well as VO2max and VVo2max using the Rockport and the 5-minute running test. Fasting blood samples as well as an appetite questionnaire with a visual analog scale (VAS) will be taken 48 hours before the first session and after the last session of training to determine the indicators of ghrelin, GLP-1, PYY, and the sensation of satiety. Also, the calorie intake and consumption will be measured before and after 4 and 8 weeks.
Participants/Inclusion and exclusion criteria
Men with BMI over 25 Between 20-30 years old Without chronic diseases Without surgery last year No consumption of weight-loss and anti-inflammatory drugs during the last year Lack of weight loss during the last year(more than 10%) Lack of programmed training during last year Lack of medical limitation. Smoking and alcohol consumption
Intervention groups
3 groups of 10 people include the high-intensity interval training (HIIT) group, the high-intensity interval functional training (HIFT) group, and the control group (Con).
Main outcome variables
changes in ghrelin, GLP-1, PYY, appetite, and body composition.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191207045644N2
Registration date: 2024-03-04, 1402/12/14
Registration timing: prospective

Last update: 2024-03-04, 1402/12/14
Update count: 0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Vahid Fekri Kourabbaslou
Name of organization / entity
The University of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 41 3288 2094
Email address
vfekri28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Eight Weeks of two types of High-Intensity Interval Training on Appetite sensation, Appetite-related Hormones and Body Composition in Overweight and Obese Men
Public title
Effect High-Intensity Interval Training on Appetite-related Hormones and Body Composition in Overweight and Obese Men
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Men with BMI over 25 Between 20-30 years old Without any chronic diseases Without any surgery during last year No consumption of weight-loss and anti-inflammatory drugs during the last year Lack of weight loss during the last year(more than 10%) Lack of any programmed training experience during last year Lack of any medical limitation.
Exclusion criteria:
Men with BMI below 25 Not being in the age range. History of chronic diseases. Experience of regular training program during the last year. Having surgery during the last year. Consumption of weight-loss and anti-inflammatory drugs during the last year Medical limitation. Consumption of supplement affecting muscle and adipose tissue metabolism during the last months. Being female. Smoking and alcohol consumption
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with dice-throw. So there are 3 groups. If the dice number is 1 or 2, in the first group, if 3 and 4 are in group 2, and if 5 and 6 are in group 3.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committees of University of Tabriz
Street address
University of Tabriz, 29 Bahman Boulevard, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2023-07-09, 1402/04/18
Ethics committee reference number
IR.TABRIZU.REC.1402.042

Health conditions studied

1

Description of health condition studied
Not a disease (Hormonal levels, Body composition, Aerobic power and Performance)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Ghrelin Hormone level
Timepoint
Pre and Post 8 weeks
Method of measurement
Blood sample

2

Description
Glucagon-like peptide 1 hormone lavel
Timepoint
Pre and Post 8 weeks
Method of measurement
Blood sample

3

Description
Peptide YY hormone level
Timepoint
Pre and Post 8 Weeks
Method of measurement
Bloos Sample

4

Description
body Composition
Timepoint
Pre and Post 8 Weeks
Method of measurement
Bioelectrical impedance analysis

5

Description
Appetite sansation
Timepoint
Pre and Post 8 Weeks
Method of measurement
Appetite questionnaire

Secondary outcomes

1

Description
Vo2 max
Timepoint
Pre and Post 8 weeks
Method of measurement
Rockport test

2

Description
vVo2max
Timepoint
Pre and Post 8 weeks
Method of measurement
5 minutes vVo2max run test

3

Description
Calorie intake
Timepoint
Pre, Post 4 and 8 weeks
Method of measurement
Dietary Recall Questionnaire

Intervention groups

1

Description
Intervention group: 8 weeks of high-intensity interval training/ 3 sessions in a week according to vVo2max
Category
N/A

2

Description
Intervention group: 8 weeks of high intensity functional training/ 3 sessions in a week including 6 full body exercises.
Category
N/A

3

Description
Control group: Daily activity without training
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
The University of Tabriz
Full name of responsible person
Ramin Amirsasan
Street address
Sports science faculty, THe University of Tabriz, Abresan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3255
Email
amirsasan@tabrizu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tabriz
Full name of responsible person
Ramin Amirsasan
Street address
Sports Science Faculty, The University of Tabriz, Abresan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3255
Email
amirsasan@tabrizu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tabriz
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
The University of Tabriz
Full name of responsible person
Vahid Fekri Kourabbaslou
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
No3, Vatan pour alley- Ostad Jafari street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5186843787
Phone
+98 41 3285 0094
Email
vfekri28@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Vahid Fekri Kourabbaslou
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
No3, Vatan pour alley- Ostad Jafari street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5186843787
Phone
+98 41 3285 0094
Email
vfekri28@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Vahid Fekri Kourabbaslou
Position
PH.D candidate
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
No 3, Vatan Pour alley, Hammam alley, Ostad jafari street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5186843787
Phone
+98 41 3285 0094
Email
vfekri28@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Hormone levels and appetite sensation, and body composition data
When the data will become available and for how long
Start accessing 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To investigate the background of research in similar research
From where data/document is obtainable
Vahid Fekri Kourabbaslou
What processes are involved for a request to access data/document
Send an Email to the researcher
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