Determining the effect of resistance training along with iso-V isolated supplementation on the serum levels of some myokines of muscle growth in middle-aged men
Design
The clinical trial with a control group is conducted in a factorial, random manner and finally on 32 people.
They are divided into 4 groups of 8 people: control, exercise, supplement, and supplement-exercise group.This research is done without blinding.
Settings and conduct
The supplement should be taken 6 days a week and 2 times a day, 25 grams each time. An adaptation training program is designed for 2 weeks and then the main resistance training (with reference) for 3 days a week. Islamic Azad University, Shushtar branch, the main place Presentation of the thesis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Men with an age range of 40 to 45 years
healthy people
People with at least 3 years of inactivity
People who are committed to research rules.
Exclusion criteria:
Lack of cooperation in research
Taking drugs that affect research during work
People who do not participate in regular exercise.
People who had practiced at the beginning of the research are not allowed to enter.
Intervention groups
Control group of sedentary healthy people (Healthy people without underlying disease)
supplement: ISOV isolated supplement: This supplement is given to a group with a special method and amount under the supervision of a researcher. Every day, the supplement is used twice in the morning and in the evening in a certain amount during 6 days of the week. (2 grams per body weight)
Training: Resistance training is done with special planning and 3 days a week. .
Main outcome variables
Changes in serum levels of muscle growth myokines
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240424061553N1
Registration date:2024-06-11, 1403/03/22
Registration timing:registered_while_recruiting
Last update:2024-06-11, 1403/03/22
Update count:0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
Morahareh Shekarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 2252
Email address
m.shekarian62@cfu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
2024-05-03, 1403/02/14
Actual recruitment end date
2024-07-20, 1403/04/30
Trial completion date
2024-09-10, 1403/06/20
Scientific title
The effect of resistance training with supplementation of iso whey on serum levels myokines of muscle growth in middle-aged men
Public title
Investigating resistance training with mecinin supplementation on middle-aged mens muscles
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least 40 years old
Healthy
Did not exercise
Absence of underlying disease
Not using a specific drug
Exclusion criteria:
Age over 45
Having diabetes and high blood fat
Having fatty liver
Lack of physical health
Taking a specific drug
Age
From 40 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
2 blood samples before and after the test
Actual sample size reached:
2
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: They were chosen completely randomly from the society. Healthy men aged 40 to 45 years were randomly selected among the visitors to the sports club who have been sedentary in the last 3 years.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
To control muscle atrophy in adults
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University - Behbahan Branch
Street address
University Street
City
Behbahan
Province
Khouzestan
Postal code
6361713198
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.IAU.BEHBAHAN.REC.1403.001
Health conditions studied
1
Description of health condition studied
Muscle atrophy is a natural physiological process of the body
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increasing serum levels of muscle growth myokines such as flustatin, which leads to increased muscle hypertrophy.
Timepoint
2 days before the start of the test and 8 weeks after the test, blood serum levels are analyzed for the analysis of myokines.
Method of measurement
By ELISA method and with a special kit Zelbio, Germany
2
Description
Reducing the serum levels of muscle myokines such as myostatin, which leads to a decrease in muscle atrophy and an increase in hypertrophy.
Timepoint
2 days before the start of the research and 8 weeks after the research, the amount of myokines will be measured through blood serum.
Method of measurement
In the pre-test and post-test phase, the muscle mass is measured with a body analyzer and the blood serum is checked with the ELISA method.
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
The first intervention group: It includes people who have resistance training with intensity and repetition appropriate to the individual and three days a week.
Category
Prevention
2
Description
The second intervention group: People who receive V-Isolate supplement of Applied UK company six days a week and two servings of twenty-five grams each day.
Category
Prevention
3
Description
The third intervention group: the group that took 50 grams of ISOV supplement six days a week and twice a day along with resistance training that was done three times a week.
Category
Prevention
4
Description
Control group: which do not receive any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr and Mah Sports Club 1
Full name of responsible person
Dr.Meysam Shabaninia
Street address
Phase 6 of Mehrumah Park
City
Bandar Mahshahr
Province
Khouzestan
Postal code
6351899351
Phone
+98 61 5235 0560
Email
m.shekariann@gmail.com
2
Recruitment center
Name of recruitment center
Shir Alinejad Sports Club
Full name of responsible person
Dr.Meysam Shabaninia
Street address
Naft St. Industrial Area
City
Bandar Mahshahr
Province
Khouzestan
Postal code
6351654758
Phone
+98 916 354 8036
Email
m.shekariann@gmail.com
3
Recruitment center
Name of recruitment center
Mehr and Mah Sports Club 2
Full name of responsible person
Dr. Meysam Shabaninia
Street address
Street naft
City
Bandar Mahshahr
Province
Khouzestan
Postal code
6351899351
Phone
+98 916 354 6157
Email
m.shekariann@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Hossein Ghorbanizadeh Kharrazi
Street address
Shoushtar.islamic azad univercity Blvd
City
Shoushtar
Province
Khouzestan
Postal code
6451741117
Phone
+98 916 354 8036
Email
info@iau-shoushtar.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
5
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Motahareh.shekarian
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Street azad univercity
City
Bandar mahshahr
Province
Khouzestan
Postal code
6351899351
Phone
+98 61 5238 1560
Email
m.shekariann@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Motahareh shekarian
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Hakim 1 St
City
Bandar mahshahr
Province
Khouzestan
Postal code
6351899351
Phone
+98 61 5238 1560
Email
m.shekariann@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Motahareh shekarian
Position
Professor
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
univercity St
City
Shoushtar
Province
Khouzestan
Postal code
6451741117
Phone
+98 61 362324919
Email
m.shekariann@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I don't decide to publish until I get the result
When the data will become available and for how long
8 weeks
To whom data/document is available
Supervisor
Under which criteria data/document could be used
If successful in the results
From where data/document is obtainable
Apply by email and call number 09166549097 m.shekariann@gmail.com
What processes are involved for a request to access data/document
Apply by email and call number 09166549097
m.shekariann@gmail.com