Protocol summary

Summary
(1) Objectives: The aim of this study was to investigate the effect of high intensity interval training (HIIT) and L-Arginine (L-Arg) supplementation on serum level of Irisin and percent of body fat in obese and overweight subjects. (2) Design: 40 healthy obese and overweight young men volunteers (mean age 24.58±6.52 years and body mass index 29.43± 3.66 kg/m2) were selected and they randomly assigned into 4 groups of HIIT, supplementation with L-Arg, L-Arg+HIIT and control. (3) Setting and conduct: Blood sampling and measurement of body fat percent was done 24 hours before and 48 hours after exercise training program and supplementation. (4) Being obese or overweight, lack of risk of cardiovascular and renal diseases were the main inclusion criteria. (5) Intervention: The training program consisted of 6 weeks of HIIT training (3 days/week). L-Arg supplementation consumed orally 6 gr/day. (6) Main outcome measures: It is expected that interventions are effective in improving obesity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041327365N1
Registration date: 2016-05-08, 1395/02/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
Sadegh Cheragh Birjandi
Name of organization / entity
University of Birjand
Country
Iran (Islamic Republic of)
Phone
+98 56 3220 2032
Email address
s.birjandi@post.birjand.ac.ir
Recruitment status
Recruitment complete
Funding source
General Administration of Sport and Youth of South Khorasan
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-04-09, 1394/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high intensity interval training and L-Arginine supplementation on serum level of Irisin and percent of body fat in obese and overweight men
Public title
The effect of high intensity interval training and L-Arginine on Brown adipose tissue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being obese or overweight, lack of risk of cardiovascular and renal diseases,avoiding the use of tobacco and alcohol, and lipid-lowering and blood sugar drugs without using any dietary supplement including L-Arg. Exclusion criteria: not wanting to continue collaborating subjects during the study or practice and any damage during execution of training.
Age
From 21 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Birjand
Street address
University of Birjand, Birjand-Zahedan road 5Km, Birjand, South Khorasan State
City
Birjand
Postal code
97175-615
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
321

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Irisin
Timepoint
24 hours before intervention, 48 hours after intervention
Method of measurement
Human Elisa Kit

2

Description
Fat percent
Timepoint
24 hours before intervention, 48 hours after intervention
Method of measurement
Body analyzer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: High intensity training, 3 times per week, for 6 weeks accompanied by corn starch as placebo
Category
Treatment - Other

2

Description
Intervention group 2: High intensity training 3 times per week for 6 weeks accompanied by L-Arginine consumption 6 gr/day for 6 weeks
Category
Treatment - Other

3

Description
Intervention group 3: L-Arginine consumption, 6 gr/day for 6 weeks.
Category
Treatment - Drugs

4

Description
Control group: Corn starch consumption as placebo 6 gr/day for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University Birjand branch
Full name of responsible person
Kazem Cheragh Birjandi (Phd student, teacher)
Street address
Islamic Azad University Birjand branch, Ghaffari Avenue, Birjand
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
South Khorasan general Administration of Sport and Youth
Full name of responsible person
Zeynab Nezamdoost
Street address
Shahid Beheshti avenue 28, Birjand, South Khorasan
City
Birjand
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
South Khorasan general Administration of Sport and Youth
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Birjand
Full name of responsible person
Marziyeh Saghebjoo
Position
Phd, . Associate Professor in Exercise Physiology
Other areas of specialty/work
Street address
, Department of Physical Education, Faculty of Physical Education and Sport Sciences, University of Birjand, Birjand, South Khorasan
City
Birjand
Postal code
97175-615
Phone
+98 56 3220 2032
Fax
+98 56 3220 2032
Email
saghebjoo@yahoo.comcontact@birjand.ac.ir
Web page address
http://birjand.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Birjand
Full name of responsible person
Sadegh Cheragh Birjandi
Position
Phd student
Other areas of specialty/work
Street address
Department of Physical Education, Faculty of Physical Education and Sport Sciences, University of Birjand, Birjand, South Khorasan
City
Birjand
Postal code
Phone
+98 563202032
Fax
+98 563202032
Email
s.birjandi@post.birjand.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Birjand
Full name of responsible person
Sadegh Cheragh Birjandi
Position
Phd student
Other areas of specialty/work
Street address
Department of Physical Education, Faculty of Physical Education and Sport Sciences, University of Birjand, Birjand, South Khorasan
City
Birjan
Postal code
97175-615
Phone
+98 56 3220 2032
Fax
+98 56 3220 2032
Email
s.birjandi@post.birjand.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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