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The effect of 6 weeks of high-intensity interval training (HIIT) with supplementation of Omega-3 on serum levels of brain-derived neurotrophic factor (BDNF) in sedentary male students

Protocol summary

Study aim
The effect of 6 weeks of High-intensity interval training(HIIT) with omega-3 supplementation on serum levels of brain-derived neurotrophic factor (BDNF) was inactive male students.
Design
Clinical trials with the control group, Pragmatic, With parallel groups, Not blind and Randomized.
Settings and conduct
Place of research of Sistan and Baluchestan University, Physical Education Hall, Subjects in each intervention group belonging to that group, High-intensity interval training (40 Meter speeds back and forth), Usage of omega-3 supplementation (2 grams daily), Do both interventions (High-intensity interval training plus omega-3 consumption) Or intervention control group (Without physical activity and supplementation) they did.
Participants/Inclusion and exclusion criteria
log in: healthy, Completion of consent form, Lack of supplement or medication, Lack regular exercise, No smoking. No entry: Failure to complete the consent form, Taking medicine or supplement, Heart or respiratory disease, Being athlete.
Intervention groups
Control group: During this 6-week period, No activity or consumption will have any supplement. First Intervention group: High-Intensity interval training (40 m round trip speed for 6 weeks, 4 repetitions in the first week and 8 repetitions in the sixth week). Along with taking 2 grams of omega-3 jelly capsules made by Zahravi Iran Co. at breakfast and dinner1 gram plus one glass of water for 6 weeks. Second Intervention group: High-Intensity interval training (40 m round trip speed for 6 weeks, 4 repetitions in the first week and 8 repetitions in the sixth week). Third Intervention group: with taking 2 grams of omega-3 jelly capsules made by Zahravi Iran Co. at breakfast and dinner1 gram plus one glass of water for 6 weeks.
Main outcome variables
Increased serum BDNF, Improve body composition indicators, Improve Indicators Hematology and lipid profiles.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181227042149N1
Registration date: 2019-02-23, 1397/12/04
Registration timing: retrospective

Last update: 2019-02-23, 1397/12/04
Update count: 0
Registration date
2019-02-23, 1397/12/04
Registrant information
Name
sajjad karimi pour
Name of organization / entity
The University of Sistan & Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3113 6456
Email address
sajad.karimi1819@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-09-26, 1397/07/04
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2018-09-26, 1397/07/04
Trial completion date
2018-11-21, 1397/08/30
Scientific title
The effect of 6 weeks of high-intensity interval training (HIIT) with supplementation of Omega-3 on serum levels of brain-derived neurotrophic factor (BDNF) in sedentary male students
Public title
Effect of physical activity and supplementation on BDNF index
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Completion of consent form for cooperation in research work. Non-public physical education physical education male students that have 1 to select units. Subjects do not have regular physical activity during the last 6 months. At least 6 months before the start of the study, they did not use omega-3 supplements, antioxidants or certain medications. Lack of specific disease and having physical health of subjects. Non-use of cigarettes and tobacco.
Exclusion criteria:
Physical Education Students or Students who Have Elected Physical Education 2. Failure to complete the consent form for cooperation in the research project. Subjects with respiratory, cardiac or other diseases. Subjects use a specific drug or supplement 6 months before or at the present time. Subjects have regular activities such as walking, bodybuilding, soccer and ... in the last 6 months or now. Smoking or tobacco use.
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method, Simple random units (groups) are selected in lottery form, Then all the names of the people are in the envelopes and each of them is selected by lot.
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 Sport Sciences Research Institute of Iran
Street address
No. 3, - Alley 5., - Miremad Street., Professor Motahhari Street
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2018-06-25, 1397/04/04
Ethics committee reference number
IR.SSRC.REC.1397.238

Health conditions studied

1

Description of health condition studied
healthy people
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum levels of Brain-derived neurotrophic factor (BDNF)
Timepoint
Measuring serum BDNF levels at the beginning of the study 24 hours before the start of the The first session of the training and at the end (6 weeks) 48 hours after the last training session.
Method of measurement
Blood serum sampling-Laboratory kit for serum human BDNF

Secondary outcomes

1

Description
Hematology Indicators
Timepoint
At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol
Method of measurement
American Sysemox Electron Microscope

2

Description
Weight
Timepoint
At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol
Method of measurement
German Seca Digital Scale

3

Description
Blood pressure
Timepoint
At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol
Method of measurement
Pressure gauge Japanese ALPK2

4

Description
Body fat percentage
Timepoint
At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol
Method of measurement
Japan's Caliph Yagamy

5

Description
Maximum Oxygen Consumption
Timepoint
At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol
Method of measurement
Test a mile running in the field

6

Description
Body mass index
Timepoint
Measuring serum BDNF levels at the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol
Method of measurement
Digital scales and gauges German Seca Model

7

Description
Waist to hip
Timepoint
َََAt the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol
Method of measurement
Strip meter

8

Description
Lipid Profiles
Timepoint
َََAt the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol
Method of measurement
Blood serum sampling, Special kits

9

Description
Dietary control of subjects
Timepoint
Once at the beginning of the research protocol (first week), again at the end of the week (Sixth week), three consecutive days(Includes two non-holiday days and one day end weekend)
Method of measurement
Using a 24-hour questionnaire, the dietary reminder was completed by the subjects, Calculated by the researcher by referring to the guidebook on nutritional value of Iranian diets

Intervention groups

1

Description
Control group: During this 6-week period, no activity will be involved, nor will any use be made.
Category
Prevention

2

Description
First Intervention group: High-Intensity interval training (40 m round trip speed for 6 weeks, 4 repetitions in the first week and 8 repetitions in the sixth week). Along with taking 2 grams of omega-3 jelly capsules made by Zahravi Iran Co. at breakfast and dinner1 gram plus one glass of water for 6 weeks.
Category
Prevention

3

Description
Second Intervention group: High-Intensity interval training (40 m round trip speed for 6 weeks, 4 repetitions in the first week and 8 repetitions in the sixth week).
Category
Prevention

4

Description
Third Intervention group: with taking 2 grams of omega-3 jelly capsules made by Zahravi Iran Co. at breakfast and dinner1 gram plus one glass of water for 6 weeks.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Sistan and Baluchestan
Full name of responsible person
Sajjad karimi pour
Street address
Nikbakht School of Engineering, University of Sistan and Baluchestan, University Boulevard
City
Zahdan
Province
Sistan-va-Balouchestan
Postal code
98798155
Phone
+98 54 3113 6456
Email
info@usb.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Sistan and Baluchestan
Full name of responsible person
Sajjad karimi pour
Street address
Nikbakht School of Engineering, University of Sistan and Baluchestan, University Boulevard
City
Zahdan
Province
Sistan-va-Balouchestan
Postal code
98798155
Phone
+98 54 3113 6456
Email
info@usb.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 Sistan and Baluchestan
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Sistan and Baluchestan
Full name of responsible person
Sajjad karimi pour
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Nikbakht School of Engineering, University of Sistan and Baluchestan, University Boulevard
City
Zahdan
Province
Sistan-va-Balouchestan
Postal code
98798155
Phone
+98 54 3113 6456
Email
info@usb.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Sistan and Baluchestan
Full name of responsible person
Sajjad karimi pour
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Nikbakht School of Engineering, University of Sistan and Baluchestan, University Boulevard
City
Zahdan
Province
Sistan-va-Balouchestan
Postal code
98798155
Phone
+98 54 3113 6456
Email
sajad.karimi1819@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Sistan and Baluchestan
Full name of responsible person
Sajjad Karimi pour
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Nikbakht School of Engineering, University of Sistan and Baluchestan, University Boulevard
City
Zahdan
Province
Sistan-va-Balouchestan
Postal code
98798155
Phone
+98 54 3113 6456
Email
sajad.karimi1819@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
Total data
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic institutions and scientific, People working in medicine and industry
Under which criteria data/document could be used
For future research and any kind of analysis is allowed.
From where data/document is obtainable
Refer to postal address Nikbakht School of Engineering, University of Sistan and Baluchistan, University Boulevard- Zahedan- Sistan and Baluchestan for correspondence, Or email address sajad.kerimi1819@gmail.com, Or call With mobile number 09150369859, in the name of Sajjad Karimi pour to answer and receive the documents or data you want
What processes are involved for a request to access data/document
After verifying the identity of the requesting person and the agreement of the professor's Help and Advisor also the relevant university, the main findings will be sent to the person.
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