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Comparative Effects of Different-Intensity Concurrent Training on Metabolic, Inflammatory, and Innate Immune Markers in Individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Clinical Trial

Protocol summary

Study aim
investigate and compare the effects of different-intensity concurrent training modalities Combined Training Protocol on metabolic, inflammatory, and innate immune markers in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease .
Design
This randomized controlled clinical trial used a three-arm parallel-group design to compare the effects of different-intensity concurrent training modalities. After eligibility assessment and informed consent, participants were randomly allocated to RT+HIIT, RT+MICT, or control groups. The exercise groups completed a 12-week intervention (three sessions per week), and outcomes were assessed before and after the intervention.”
Settings and conduct
This study was designed and supervised by the University of Tehran. The 12-week exercise protocol was conducted at Shahid Kazemian High School Sports Complex in Mashhad under the supervision of researchers. Blood samples were collected before and after the intervention and transferred to the laboratory for analysis.
Participants/Inclusion and exclusion criteria
Participants aged 25–45 years with MASLD confirmed by liver ultrasonography and metabolic risk factors were included. Absence of regular exercise during the previous six months and medical eligibility for exercise participation were required. Individuals with cardiovascular disease, non-MASLD chronic liver diseases, insulin-dependent diabetes, or contraindications to exercise were excluded.
Intervention groups
Group 1: Resistance Training + High-Intensity Interval Training (RT+HIIT) Group 2: Resistance Training + Moderate-Intensity Continuous Training (RT+MICT) Group 3: Control Group
Main outcome variables
“The primary outcomes of this study were changes in the expression of Toll-like receptor 4 (TLR4) and Dectin-1 (CLEC7A) genes in peripheral blood mononuclear cells (PBMCs) following the 12-week exercise intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260531069583N1
Registration date: 2026-07-20, 1405/04/29
Registration timing: retrospective

Last update: 2026-07-20, 1405/04/29
Update count: 0
Registration date
2026-07-20, 1405/04/29
Registrant information
Name
Mohammadreza Sharbati
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 0551
Email address
mr.sharati@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-05, 1405/01/16
Expected recruitment end date
2026-04-09, 1405/01/20
Actual recruitment start date
2026-04-05, 1405/01/16
Actual recruitment end date
2026-04-09, 1405/01/20
Trial completion date
2026-05-26, 1405/03/05
Scientific title
Comparative Effects of Different-Intensity Concurrent Training on Metabolic, Inflammatory, and Innate Immune Markers in Individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Clinical Trial
Public title
Effects of Different-Intensity Concurrent Training on Metabolic and Inflammatory Health Indicators in Individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) confirmed by hepatic steatosis on ultrasonography along with the presence of metabolic risk factors. No participation in regular structured exercise programs during the previous six months. Medical clearance for participation in exercise training and absence of any contraindication to physical activity
Exclusion criteria:
Cardiovascular disease, uncontrolled hypertension, or any medical condition contraindicating exercise participation. Secondary chronic liver diseases, insulin-dependent diabetes mellitus, or severe musculoskeletal disorders limiting exercise performance. Use of medications or conditions that may substantially affect metabolic or inflammatory responses
Age
From 25 years old to 45 years old
Gender
Both
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
Two fasting blood samples were collected from each participant before and after the 12-week exercise intervention. Blood samples were used for the assessment of biochemical parameters, inflammatory markers, complete blood count indices, and innate immune-related gene expression
Actual sample size reached: 30
More than 1 sample in each individual
Actual sample size in each individual: 2
Two fasting blood samples were collected from each participant before and after the 12-week exercise intervention. Blood samples were used for the assessment of biochemical parameters, inflammatory markers, complete blood count indices, and innate immune-related gene expression
Randomization (investigator's opinion)
Randomized
Randomization description
After completion of the baseline assessments, participants were randomly assigned to one of the three study groups using a computer-generated random allocation sequence created in Microsoft Excel (Microsoft Corp., USA). The random sequence was generated before participant assignment, using a 1:1:1 allocation ratio to ensure equal distribution among the RT+HIIT, RT+MICT, and control groups. Each participant was assigned to a group according to the order specified in the predefined randomization sequence, and the allocation process was performed independently of baseline measurements and intervention outcomes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a randomized controlled clinical trial with a three-arm parallel-group design, including two exercise intervention groups (RT+HIIT and RT+MICT) and a control group. The intervention lasted 12 weeks, and assessments were performed before and after the intervention.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Sport Sciences and Health, University of Tehran
Street address
Faculty of Sport Sciences and Health, University of Tehran, North Kargar Street, Tehran, Islamic Republic of Iran
City
tehran
Province
Tehran
Postal code
۱۴۱۷۹۳۵۸۴۰
Approval date
2026-03-16, 1404/12/25
Ethics committee reference number
IR.UT.SPORT.REC.1404.244

Health conditions studied

1

Description of health condition studied
Metabolic Dysfunction-Associated Steatotic Liver Disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Changes in innate immune-related gene expression, including TLR4 and Dectin-1 (CLEC7A), in peripheral blood mononuclear cells (PBMCs) following the 12-week exercise intervention were assessed as primary outcomes.”
Timepoint
Before the intervention and after completion of the 12-week training program
Method of measurement
TLR4 and Dectin-1 (CLEC7A) gene expression in peripheral blood mononuclear cells (PBMCs) was measured using real-time quantitative PCR (RT-qPCR) and calculated using the 2^-ΔΔCt method

2

Description
Changes in liver enzymes, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST), following the 12-week exercise intervention
Timepoint
Before the intervention and after completion of the 12-week training program
Method of measurement
Serum ALT and AST levels were measured using standard biochemical laboratory methods

3

Description
Changes in systemic inflammatory markers, including high-sensitivity C-reactive protein (hs-CRP) and inflammatory ratios (NLR, PLR, MLR, and SIRI), following the 12-week exercise intervention
Timepoint
Before the intervention and after completion of the 12-week training program.”
Method of measurement
hs-CRP was measured using standard laboratory methods, and NLR, PLR, MLR, and SIRI were calculated based on peripheral blood cell counts

Secondary outcomes

1

Description
Changes in metabolic parameters, including fasting blood glucose and lipid profile markers such as triglycerides (TG), total cholesterol (TC), HDL-C, and LDL-C, following the 12-week exercise intervention.
Timepoint
Before the intervention and after completion of the 12-week training program.
Method of measurement
Fasting blood glucose and lipid profile parameters were measured using standard biochemical laboratory methods.

Intervention groups

1

Description
Group 1: RT+HIIT12-week concurrent training including resistance training combined with high-intensity interval training, three sessions per week.
Category
Behavior

2

Description
Group 2: RT+MICT12-week concurrent training including resistance training combined with moderate-intensity continuous training, three sessions per week.
Category
Behavior

3

Description
Group 3: ControlParticipants maintained their usual daily activities and did not participate in a structured exercise program during the study period.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
arya hospital
Full name of responsible person
iranmanesh
Street address
Golestan Street, Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۱۴۱۷۹۳۵۸۴۰
Phone
+98 915 456 0786
Email
iranmanesh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
ut
Full name of responsible person
Dr. Rahman Souri
Street address
Faculty of Sport Sciences and Health, University of Tehran, North Kargar Street, Tehran, Iran
City
tehran
Province
Tehran
Postal code
۱۴۱۷۹۳۵۸۴۰
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
ut
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
University of Tehran
Full name of responsible person
Mohammadreza Sharbati
Position
PhD student in exercise physiology, University of Tehran
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
North Kargar St
City
Tehran
Province
Tehran
Postal code
mr.sharbati@ut.ac.ir
Phone
+98 51 3869 0551
Fax
Email
mr.sharati@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mohammadreza Sharbati
Position
PhD student in exercise physiology, University of Tehran
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
North Kargar St
City
Tehran
Province
Tehran
Postal code
mr.sharbati@ut.ac.ir
Phone
+98 51 3869 0551
Fax
Email
mr.sharati@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mohammadreza Sharbati
Position
PhD student in exercise physiology, University of Tehran
Latest degree
Master
Other areas of specialty/work
Exercise Physiologist
Street address
North Kargar St
City
Tehran
Province
Tehran
Postal code
9178164971
Phone
+98 51 3869 0551
Fax
Email
mr.sharati@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Individual participant data will not be publicly shared to protect participant confidentiality and in accordance with the informed consent obtained from participants
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
The SPSS statistical analysis syntax used in this study will be available upon reasonable scientific request. Individual participant data will not be shared to protect participant confidentiality.”
When the data will become available and for how long
From the date of publication of the study results, upon reasonable scientific request.
To whom data/document is available
The principal investigator and research team. Access by other researchers will be considered upon reasonable scientific request, subject to approval by the principal investigator and compliance with ethics requirements
Under which criteria data/document could be used
The data may be used only for scientific research, validation of study findings, and secondary analyses, subject to approval by the principal investigator and compliance with confidentiality and ethics requirements.
From where data/document is obtainable
Dr. Rahman Souri, Principal Investigator, Faculty of Sport Sciences and Health, University of Tehran.
What processes are involved for a request to access data/document
“Requests for data access should be submitted in writing to the Principal Investigator. Requests will be reviewed based on their scientific merit and approved by the Principal Investigator, subject to ethics requirements and protection of participant confidentiality.
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