Effect of combined exercise (resistance exercise and high intensity interval training) versus control group on serum sirtuin 1 and 4 levels in men with non-alcoholic fatty liver disease: a randomized clinical trial
To assess the effect of combined exercise (resistance exercise and high intensity interval training) versus control group on serum sirtuin 1 and 4 levels in men with non-alcoholic fatty liver disease
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 30 eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Gymnasium at the Faculty of Sports Sciences, Bu-Ali Sina University in Hamadan city, involving 30 eligible patients with non-alcoholic fatty liver disease. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. Blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 50 years
Non-alcoholic fatty liver grade 1 and 2
Exclusion criteria:
Heart or respiratory disease
Thyroid disorder
Diabetes
Muscle and joint disorders
Smoking and alcohol use
Intervention groups
Intervention group:
Training and routine recommendations plus combined resistance exercise and high-intensity interval training (HIIT) for 45 to 60 minutes, 3 days a week, for 12 weeks include: training at an intensity of 70% of heart rate reserve or 84% of maximum heart rate during sprints of up to 30 seconds, in the first 6 weeks with a 5-minute warm-up on a treadmill, then 4 sets of 3 minutes with 3 minutes of rest between sets, and in the second 6 weeks, 5 sets of 3 minutes with 3 minutes of rest between sets.
Control group:
Training and routine recommendations
Main outcome variables
Sirtuin 1 levels; Sirtuin 4 levels; Serum liver enzymes (ALT-AST); Serum lipid profile (LDL-HDL-CHOL-TG); Serum fasting blood glucose levels; Body mass index; Waist-hip ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N563
Registration date:2025-07-15, 1404/04/24
Registration timing:prospective
Last update:2025-07-15, 1404/04/24
Update count:0
Registration date
2025-07-15, 1404/04/24
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-01, 1404/05/10
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined exercise (resistance exercise and high intensity interval training) versus control group on serum sirtuin 1 and 4 levels in men with non-alcoholic fatty liver disease: a randomized clinical trial
Public title
Effect of combined exercise (resistance exercise and high intensity interval training) versus control group on serum sirtuin 1 and 4 levels in men with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years
Non-alcoholic fatty liver grade 1 and 2
Exclusion criteria:
Heart or respiratory disease
Thyroid disorder
Diabetes
Muscle and joint disorders
Smoking and alcohol use
Age
From 18 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
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2025-02-15, 1403/11/27
Ethics committee reference number
IR.UMSHA.REC.1403.839
Health conditions studied
1
Description of health condition studied
Fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Sirtuin 1 levels
Timepoint
Before intervention and 12 weeks later
Method of measurement
Using blood sampling
2
Description
Sirtuin 4 levels
Timepoint
Before intervention and 12 weeks later
Method of measurement
Using blood sampling
3
Description
Serum liver enzymes (ALT-AST)
Timepoint
Before intervention and 12 weeks later
Method of measurement
Using blood sampling
4
Description
Serum lipid profile (LDL-HDL-CHOL-TG)
Timepoint
Before intervention and 12 weeks later
Method of measurement
Using blood sampling
5
Description
Serum fasting blood glucose levels
Timepoint
Before intervention and 12 weeks later
Method of measurement
Using blood sampling
6
Description
Body mass index
Timepoint
Before intervention and 12 weeks later
Method of measurement
Using physical examination
7
Description
Waist-hip ratio
Timepoint
Before intervention and 12 weeks later
Method of measurement
Using physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Training and routine recommendations plus combined resistance exercise and high-intensity interval training (HIIT) for 45 to 60 minutes, 3 days a week, for 12 weeks include: training at an intensity of 70% of heart rate reserve or 84% of maximum heart rate during sprints of up to 30 seconds, in the first 6 weeks with a 5-minute warm-up on a treadmill, then 4 sets of 3 minutes with 3 minutes of rest between sets, and in the second 6 weeks, 5 sets of 3 minutes with 3 minutes of rest between sets.
Category
Other
2
Description
Control group: Training and routine recommendations
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Gymnasium at the Faculty of Sports Sciences, Bu-Ali Sina University in Hamadan city
Full name of responsible person
Razieh Ghorbani Saber
Street address
Gymnasium at the Faculty of Sports Sciences, Bu-Ali Sina University, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
razih.saber@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
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
Hamedan University of Medical Sciences
Full name of responsible person
Razieh Ghorbani Saber
Position
Physiology student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
razih.saber@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zarei
Position
Physiologist
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zarei@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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