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IRCT20260531069583N1 IRCT 2026-07-20 ut Effects of Different-Intensity Concurrent Training on Metabolic and Inflammatory Health Indicators in Individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease 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 2026-04-05 anticipated 40 Complete https://irct.ir/trial/91680 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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, 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. N/A Metabolic Dysfunction-Associated Steatotic Liver Disease. Intervention 1: Group 1: RT+HIIT12-week concurrent training including resistance training combined with high-intensity interval training, three sessions per week. Intervention 2: Group 2: RT+MICT12-week concurrent training including resistance training combined with moderate-intensity continuous training, three sessions per week. Intervention 3: Group 3: ControlParticipants maintained their usual daily activities and did not participate in a structured exercise program during the study period. No - There is not a plan to make this available Justification or reason for not sharing IPD is Individual participant data will not be publicly shared to protect participant confidentiality and in accordance with the informed consent obtained from participants
public Mohammadreza Sharbati
North Kargar St
Tehran Iran (Islamic Republic of) mr.sharbati@ut.ac.ir +98 51 3869 0551 mr.sharati@ut.ac.ir University of Tehran scientific Mohammadreza Sharbati
North Kargar St
Tehran Iran (Islamic Republic of) mr.sharbati@ut.ac.ir +98 51 3869 0551 mr.sharati@ut.ac.ir University of Tehran Iran (Islamic Republic of) 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 25 years 45 years Both 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 K76.0 Fatty (change of) liver, not elsewhere classified Behavior Behavior N/A Group 1: RT+HIIT12-week concurrent training including resistance training combined with high-intensity interval training, three sessions per week. Group 2: RT+MICT12-week concurrent training including resistance training combined with moderate-intensity continuous training, three sessions per week. Group 3: ControlParticipants maintained their usual daily activities and did not participate in a structured exercise program during the study period. 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. 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. 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. 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. ut Approved 2026-03-16 Ethics Committee of the Faculty of Sport Sciences and Health, University of Tehran Faculty of Sport Sciences and Health, University of Tehran, North Kargar Street, Tehran, Islamic Republic of Iran tehran Tehran Iran (Islamic Republic of)