The effect of 12 weeks of combined training on the serum levels of omentin-1, fetuin B on the markers of enzymes in men with non-alcoholic fatty diseases
The effect of twelve weeks of combined training on the serum levels of omentin-1, fetuin B and liver damage markers in men with non-alcoholic fatty liver disease.
Design
The clinical trial has two control and experimental groups that are randomized and with 20 patients
Settings and conduct
All the exercises were done in the gym in Borujerd city and blood samples are gathered for the laboratory tests The subjects were divided into two experimental groups, which included combined exercise (resistance, HIIT) and the control group. A training protocol that includes 12 weeks of combined training (resistance, HIIT) during 3 sessions per week (2 resistance training sessions, 1 HIIT training session) and for 40 to 60 minutes and resistance training with an intensity of 60 to 75% of the maximum heart rate and performed HIIT at an intensity of 84% of maximum heart rate, and the control group did no exercise during the intervention period.
Participants/Inclusion and exclusion criteria
Entry requirements: having grade two and three fatty liver disease; non-smokers; non-athletes; not having diabetes and not having high blood pressure.
Exclusion criteria: smokers; athletes; having diabetes; having high blood pressure; chronic diseases; cardiovascular disease.
Intervention groups
The first group: the experimental group, which included combined resistance and interval training, and the second group, which was the control group, will not do any training during this period.
Main outcome variables
Improvement of non-alcoholic fatty liver disease
General information
Reason for update
Acronym
NAFLD
IRCT registration information
IRCT registration number:IRCT20240430061614N1
Registration date:2024-05-31, 1403/03/11
Registration timing:retrospective
Last update:2024-05-31, 1403/03/11
Update count:0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
pardis fazli malidare
Name of organization / entity
The university of bu ali sina hamedan
Country
Iran (Islamic Republic of)
Phone
+98 11 4229 4495
Email address
p.fazli@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12 weeks of combined training on the serum levels of omentin-1, fetuin B on the markers of enzymes in men with non-alcoholic fatty diseases
Public title
The effect of twelve weeks of combined training on disease damage in men with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having grade two and three non-alcoholic fatty liver disease
Exclusion criteria:
Being athletes
Smokers
Having diabetes
Having high blood pressure
Chronic diseases
Cardiovascular disease
Age
From 30 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We used Random Allocation Software for randomization. Random codes were generated in blocks 4 and 6. We used sequentially numbered sealed opaque envelopes to conceal the allocation. The second researcher, who was not involved in data collection and was not aware of the study process, opened the envelopes containing the random codes and delivered them to the patients. As a result, patients were randomly assigned to experimental and control groups with a rate of 1:1.
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
Boali Sina University, Hamedan
Street address
Boali Sina University, Shahid Mostafa Ahmadi Roshan, Chaharbagh
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.BASU.REC.1402.074
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K70-K77
ICD-10 code description
بیماری کبد چرب غیر الکلی
Primary outcomes
1
Description
Liver enzymes (ALT, AST, ALP)
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
Before and after the intervention, blood samples will be measured with diagnostic kits for enzymes in the laboratory.
2
Description
Omentin-1
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
ELISA method.
3
Description
Fetuin-B
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
ELISA method.
4
Description
Ultrasound of the liver
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
Using an ultrasound device, the intervention will be performed before and after 12 weeks.
Secondary outcomes
1
Description
Fasting Blood Sugar(FBS)
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
ELISA method.
2
Description
Triglycerides (TG)
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
ELISA method.
3
Description
Cholesterol(CHO)
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
ELISA method
4
Description
Low-density lipoprotein cholesterol (LDL)
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
ELISA method
5
Description
High-density lipoprotein cholesterol (HDL)
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
ELISA method
6
Description
Waist-Hip Ratio (WHR)
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
WHR is evaluated using Anya's three-dimensional body analyzer device, before and after the intervention, and then the final information is taken from the device.
7
Description
Body Fat Percentage
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
The percentage of body fat is evaluated using Anya's 3D body analyzer before and after the intervention, and then the final information is taken from the device.
8
Description
Vo2max
Timepoint
The time period of outcome measurement will be implemented before the intervention and 12 weeks after the intervention.
Method of measurement
The maximum oxygen consumption is measured by the Bruce test before and after the intervention. This Bruce test is performed on a treadmill.
Intervention groups
1
Description
Intervention group: The training protocol includes a combination of resistance training and high-intensity interval training (HIIT) for 12 weeks, three sessions per week, two sessions of which are resistance training and one HIIT session, which lasts 45 to 60 minutes. HIIT exercises will be performed at an intensity of 77% of the reserve heart rate or 84% of the maximum heart rate. The sessions of this exercise in the first 6 weeks will be 5 minutes of warming up with a treadmill, and then 4 sets of 3 minutes with 3 minutes of rest between sets will be done, and in the second 6 weeks, 5 sets of 3 minutes with 3 minutes of rest between sets will be done. , and at the end of each training session, 5 to 10 minutes of walking and stretching will be done.
Category
Treatment - Other
2
Description
Control group: They did not do any exercise during the intervention, they only took blood tests before and after the exercise, and according to the experimental group, all the factors that were measured there were also measured in the control group. And the control group was also advised to refrain from intense activities during the research period and to do their daily activities as before without doing intense activities.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Boroujerd ultrasound centers
Full name of responsible person
Pardis Fazli Mali Dare
Street address
Central Ultrasound, Shahid Sohrabi Street, Hafez Street, Borujerd Shahada
City
Borujerd
Province
Lorestan
Postal code
4778119967
Phone
+98 903 061 2361
Email
pardisfazli078@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bo Ali Sina University, Hamedan
Full name of responsible person
Dr. Ali Heidarianpour
Street address
Boali Sina University, Shahid Mostafa Ahmadi Roshan, Chaharbagh
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 918 818 7984
Email
heidarian317@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
There is no source of financial support
Proportion provided by this source
1
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Boali Sina University, Hamedan
Full name of responsible person
Dr. Ali Heydarianpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sports Sciences, Bo Ali Sina University, Shahid Mostafa Ahmadi Roshan, Chaharbagh
City
Hamedan
Province
Hamadan
Postal code
165178-38695
Phone
+98 918 818 7984
Email
heidarian317@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bo Ali Sina University, Hamedan
Full name of responsible person
Dr. Ali Heydarianpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sports Sciences, Bo Ali Sina University, Shahid Mostafa Ahmadi Roshan, Chaharbagh
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 918 818 7984
Email
heidarian317@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bo Ali sina university Hamedan
Full name of responsible person
Pardis Fazli Mali Dare
Position
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Boali Sina University, Shahid Mostafa Ahmadi Roshan, Chaharbagh
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 903 061 2361
Email
pardisfazli078@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data and documents can be shared, but with the non-identification of people and the preservation of private information of subjects
When the data will become available and for how long
The results of this study will be available 3 months after publication in journals.
To whom data/document is available
The results of the studies will be accessible to all members of the society without any restrictions.
Under which criteria data/document could be used
The presented documents can be useful for improving non-alcoholic fatty liver disease.
From where data/document is obtainable
Email Pardis Fazli
pardisfazli078@gmail.com
What processes are involved for a request to access data/document
When the applicant provides documents for her field of work related to the subject of the thesis and in case of a reasonable request and a commitment not to misuse the data of this research, the data will be sent to her for 1 working week.