The effect of eight weeks high intensity interval training on mir-27a expression and serum levels of C-reactive protein (CRP) in Middle-Aged Obese Men
Design
The clinical trial will consist of two groups. Twenty-four obese middle-aged men (voluntarily) will be divided into two groups of intervention (Interval training) and control (without intervention) with random arrangement (simple randomization). The present design will be a semi-experimental and single blind.
Settings and conduct
In a quasi-experimental research project, 24 obese middle-aged men (40 to 50 years old) were considered as a research sample. Subjects will be randomly divided into 2 groups of 12: control and High Intensity Interval Training (HIIT). The training protocol is performed 3-4 days a week for eight weeks. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session. All measurements and exercises will be measured in the Tabriz Technical and Vocational University.
Participants/Inclusion and exclusion criteria
inclusion criteria: obese middle-aged men aged 40 to 50 years, without cardio-respiratory problems, body mass index (BMI) above 30 (BMI>30), inactive (less than 90 minutes of regular exercise per week), no medication, and anabolic supplements, Blood pressure, anti-inflammatory, and antioxidant. exclusion criteria: Chronic diseases (such as cardiovascular disease, cancer or respiratory diseases), smoking and BMI<30.
Intervention groups
Two groups: 1- High Intensity Interval Training (HIIT) and 2- Control Group (will do nothing)
Main outcome variables
mir-27a and C-reactive protein (CRP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220128053844N1
Registration date:2022-03-16, 1400/12/25
Registration timing:retrospective
Last update:2022-03-16, 1400/12/25
Update count:0
Registration date
2022-03-16, 1400/12/25
Registrant information
Name
hamid reza zolfi
Name of organization / entity
Technical and vocational university
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 9011
Email address
hzolfi@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of high-intensity interval training (HIIT) on mir-27a and C-reactive protein levels in obese middle-aged men
Public title
Effect of exercise training on obse men
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 40 to 50 years
body mass index above 30
Exclusion criteria:
Smoking
Blood sugar is above the normal range
Blood lipids are above the normal range
Taking certain medications to control body weight and blood pressure during the last three months
Diastolic and systolic pressures greater than 100 and 140 mm Hg, respectively
Age
From 40 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning samples using simple random-lottery method. In this method, first the list of names of all members is obtained. It is then assigned a number to each. It is placed inside the box. The papers are then selected and removed individually until the desired sample size is complete.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is performed in a single blind manner and the only researchers knows how to assign individuals to different groups.In general, all participants in this project are unaware of what kind of sports group they are said to be, and the researchers will individually give the exercise to individuals and will not be explained to people about the type and name of the exercise. Also, the data analyst, clinical caregiver, outcome assessor, as well as the safety committee and data monitoring will not know how to assign exercise.
Placebo
Not used
Assignment
Parallel
Other design features
In the present study, participants were randomly assigned to two training and control groups. The control group does not receive any intervention (exercise or supplement). Blood samples are taken from the control group only in two time periods.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Research Institute
Street address
No. 3-Fifth Alley - Mir Emad St-Ostad Motahhari St-Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2021-11-21, 1400/08/30
Ethics committee reference number
IR.SSRC.REC.1400.109
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of micro RNA27-a
Timepoint
Before and after starting eight weeks of HIIT training
Method of measurement
Real-Time PCR and using PCR mic
2
Description
The level of C-Reactive Protein (CRP)
Timepoint
Before and after starting eight weeks of HIIT training
Method of measurement
It will be measured by Elisa Reader method with high sensitivity.
Secondary outcomes
1
Description
Blood sugar
Timepoint
Before and after the start of research
Method of measurement
Using the kit of Pars Azmoun company and with the sensitivity of the kit, 5 mg / dl will be measured.
2
Description
Lipid profile
Timepoint
Before and after the start of research
Method of measurement
The test will be measured by enzymatic calorimetric method and Pars Company kit.
Intervention groups
1
Description
Intervention group: Eight weeks of high-intensity interval training (HIIT). Subjects will participate in high-intensity interval training (HIIT) 3-4 days a week for 8 weeks. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session.
Category
Prevention
2
Description
Control group: They will not do anything
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Technical and vocational university
Full name of responsible person
Hamidreza zolfi
Street address
Manzariyeh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
51749-13136
Phone
+98 41 3477 9011
Fax
+98 41 3477 9065
Email
Hamidreza.zolfi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Technical and vocational university
Full name of responsible person
Hamidreza Zolfi
Street address
Manzariyeh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
51749-13136
Phone
+98 41 3477 9011
Email
Hamidreza.zolfi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Technical and vocational university
Proportion provided by this source
10
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
East Azarbaijan Technical and Vocational University.
Full name of responsible person
Hamid Reza Zolfi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Technical and Vocational University. Manzariyeh,Tabriz,East Azerbaijan Province.
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۷۴۹۱۳۱۳۶
Phone
041 - ۳۴۷۷۹۰۱۱ -12- داخلی 291
Email
Hamidreza.zolfi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
East Azarbaijan Technical and Vocational University.
Full name of responsible person
Hamid Reza Zolfi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Technical and Vocational University. Manzariyeh,Tabriz,East Azerbaijan Province.
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۷۴۹۱۳۱۳۶
Phone
۰۴۱- ۳۴۷۷۹۰۱۱ - 12- داخلی291
Email
Hamidreza.zolfi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
East Azarbaijan Technical and Vocational University
Full name of responsible person
Hamid Reza Zolfi
Position
Assistant Professor of the University
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Manzariyeh, Tabriz, East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۷۴۹۱۳۱۳۶
Phone
۱۲ - ۳۴۷۷۹۰۱۱ - ۰۴۱ داخلی 291
Email
Hamidreza.zolfi@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
In the meetings that will be held with the participants before and after the study, all the data and their analysis, consent and trial and study protocol will be explained to them.
When the data will become available and for how long
Depending on the variable, the data of some variables will be accessed before the start of the research and others after the end of the research.
To whom data/document is available
Project participants, researchers and university professors
Under which criteria data/document could be used
Other researchers will be allowed to access the data in order to use and assist other researchers and to commit not to misuse the data.
From where data/document is obtainable
Email - In-person visit
What processes are involved for a request to access data/document
Provide identification documents and research resume and provide commitment in order not to misuse the data