Protocol summary

Study aim
The effect of 12 weeks of interval training with different intensities on serum levels of Fibroblast growth factor 21, Myostatin and Irisin in overweight and obese Men
Design
12-week training program in experimental groups 1 to 3 included heavy running from 88 to 93, a moderate intensity of 73 to 78, and a light intensity of 58 to 63 percent of maximal heart rate and three sessions per week. A sample of 47 people who were randomly (The method of tracking) assigned to 4 groups( experimental groups:12, control group:11).Before and after the training period, Irisine, FGF21 and Mayostatin serum samples were taken from all subjects in fasting state., Anthropometric measurements were also performed. clinical trial type: randomized clinical trial with control group
Settings and conduct
The training program is 12 weeks and three sessions a week. The place of the study is the sports hall in Bojnurd city. Subjects were running in the designated range of heart rates by attending at the gym (6 o'clock).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Young men (20,30) years, Having body mass index greater than 25 kg,m2 Exclusion criteria: Use of medication,Tobacco use , Having Chronic diseases, Having Regular physical activity
Intervention groups
Three intensities of interval training 1. Low (58,63%of maximal heart rate) 2. Medium (73,78%of maximal heart rate) 3. Heavy (88,93% of maximal heart rate) 4. Control (Lack of exercise )
Main outcome variables
Irisin; Myostatin; FGF21

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190719044269N1
Registration date: 2020-03-30, 1399/01/11
Registration timing: retrospective

Last update: 2020-03-30, 1399/01/11
Update count: 0
Registration date
2020-03-30, 1399/01/11
Registrant information
Name
Saeed Ramezani
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 58 3232 3963
Email address
rsaeid92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-28, 1398/07/06
Expected recruitment end date
2019-10-09, 1398/07/17
Actual recruitment start date
2019-09-28, 1398/07/06
Actual recruitment end date
2019-10-09, 1398/07/17
Trial completion date
2020-01-04, 1398/10/14
Scientific title
The effect of 12 weeks of interval training with different intensity on serum levels of Fibroblast growth factor 21, Myostatin and Irisin in obese and overweight men
Public title
The effect of interval training with different intensities on weight loss and brown adipose tissue markers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Young men (20,25) years Having a body mass index greater than 25 kg,m 2
Exclusion criteria:
Use of medication Tobacco use Having Chronic diseases Having Regular physical activity
Age
From 20 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 47
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method, Individual randomization, The method of tracking was used. Each name dropped out of the container in light, medium, heavy and control groups, respectively
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
Ethics committee of Tehran University of Medical Sciences
Street address
Enghlab Square
City
Tehran
Province
Tehran
Postal code
1417414418
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.UT.SPORT.REC.1398.051

Health conditions studied

1

Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Fibroblast growth factor 21(FGF21)
Timepoint
First and 12 weeks later
Method of measurement
ELISA laboratory method

2

Description
Myostatin
Timepoint
First and 12 weeks later
Method of measurement
ELISA laboratory method

3

Description
Irisin
Timepoint
First and 12 weeks later
Method of measurement
ELISA laboratory method

Secondary outcomes

1

Description
Body fat percentage
Timepoint
First and 12 weeks later
Method of measurement
Caliper

2

Description
Waist–hip ratio (WHR)
Timepoint
First and 12 weeks later
Method of measurement
meters

3

Description
Body Mass Index
Timepoint
First and 12 weeks later
Method of measurement
Digital scales and meters

Intervention groups

1

Description
Intervention group: heavy interval training, Three times a week, 12 weeks, with an intensity of 88-93% of maximum heart rate, Duration of activity from the beginning to the end of the protocol (25 to 60 minutes)
Category
Other

2

Description
Intervention group: medium interval training, Three times a week, 12 weeks, with an intensity of 73-78% of maximum heart rate, Duration of activity from the beginning to the end of the protocol (25 to 60 minutes)
Category
Other

3

Description
En Intervention group: low interval training,Three times a week, 12 weeks, with an intensity of 58-63% of maximum heart rate, Duration of activity from the beginning to the end of the protocol (25 to 60 minutes)
Category
Other

4

Description
Control group: Lack of exercise within 12 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farhangian university,Campus of imam mohammad bagher (AS) bojnourd
Full name of responsible person
Saeed ramezani
Street address
No. 39, Aaref 1, Chamran1 Ave., Chamran Ave
City
Bojnourd
Province
North Khorasan
Postal code
9418795569
Phone
+98 58 3232 3963
Email
rsaeid92@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Ali Asghar Ravasi
Street address
Enghelab Square
City
Tehran
Province
Tehran
Postal code
1417414418
Phone
+98 21 6111 8812
Email
publicrei@ut.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 Tehran
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 Tehran
Full name of responsible person
Saeed Ramezani
Position
The Student of PHD
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
No. 39, Aaref 1, Chamran1 Ave., Chamran Ave
City
Bojnourd
Province
North Khorasan
Postal code
9418795569
Phone
+98 58 3232 3963
Fax
Email
rsaeid92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Saeed Ramezani
Position
Student of PHD
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
No. 39, Aaref 1, Chamran1 Ave., Chamran Ave
City
Bojnourd
Province
North Khorasan
Postal code
9418795569
Phone
+98 58 3232 3963
Fax
Email
rsaeid92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Saeed Ramezani
Position
Student of PHD
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
No. 39, Aaref 1, Chamran1 Ave., Chamran Ave
City
Bojnourd
Province
North Khorasan
Postal code
9418795569
Phone
+98 58 3232 3963
Fax
Email
rsaeid92@gmail.com

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
No abuse of raw data
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is shared after being unidentified
When the data will become available and for how long
One year after the publication of the results
To whom data/document is available
All people who need this data
Under which criteria data/document could be used
Lake of Plagiarism
From where data/document is obtainable
Saeed Ramezani, rsaeid92@gmail.com
What processes are involved for a request to access data/document
A week after sending a request to Gmail and an applicant's commitment to not use the data directly
Comments
The main concern of each researcher is the misuse of others by his research information. If this item is assured, all research information will be available.
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