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IRCT20251112067968N4 IRCT 2026-09-22 Islamic Azad University Marginal effects of supervised progressive resistance training and omega-3 supplementation in adults with nonalcoholic fatty liver disease Effects of Progressive Resistance Training Combined with Omega-3 Fatty Acid Supplementation on Myokines, Oxidative Stress, and Metabolic Indices in Patients with Non-Alcoholic Fatty Liver Disease 2026-10-02 anticipated 284 Recruiting https://irct.ir/trial/93510 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Participants will be allocated in a 1:1:1:1 ratio using a computer-generated random sequence with permuted blocks of 4 and 8, stratified by sex and baseline CAP category. The allocation sequence will be generated by a statistician with no role in recruitment, intervention delivery, or outcome measurement. Personnel enrolling participants will have no access to upcoming allocations, Blinding description: Supplement assignment will be double-blinded. Blinding of participants and exercise personnel to resistance-training allocation will not be feasible. Personnel responsible for biochemical assays, biomarker measurements, controlled attenuation parameter assessment, data management, and the prespecified primary statistical analysis will remain unaware of randomized treatment codes until completion of the primary analysis. N/A Nonalcoholic fatty liver disease. Intervention 1: Resistance training plus omega-3: Participants will complete a 12-week supervised whole-body progressive resistance-training program three times per week on nonconsecutive days, with 36 scheduled sessions. They will consume four omega-3 softgels daily, providing 1.44 g/day EPA and 0.96 g/day DHA. Intervention 2: Resistance training plus placebo: Participants will complete the same 12-week supervised progressive resistance-training program three times per week on nonconsecutive days, with 36 scheduled sessions. They will consume four externally matched corn-oil placebo softgels daily. Intervention 3: Omega-3 without structured resistance training: Participants will consume four omega-3 softgels daily for 12 weeks and will maintain habitual physical activity without initiating structured resistance training. Intervention 4: Placebo without structured resistance training: Participants will consume four externally matched corn-oil placebo softgels daily for 12 weeks and will maintain habitual physical activity without initiating structured resistance training. Yes - There is a plan to make this available What will be shared: De-identified individual participant data, study protocol, statistical analysis plan, analysis codes, and data dictionary will be made available to qualified researchers after publication of the primary study results. Requests will be reviewed by the research team based on scientific and ethical considerations. When: Access to data and documents will begin 6 months after publication of the primary study results and will remain available for 5 years. To whom: Academic researchers, scientists from research institutions, and qualified investigators submitting a valid scientific request will be eligible for access. Conditions: Data will be available for scientific research purposes, valid analyses, and advancing knowledge in nonalcoholic fatty liver disease and exercise science. Data reuse must comply with research ethics principles and must not attempt participant re-identification. Where to obtain: Requests for data access should be submitted to the corresponding investigator through the official email address of the research center. Final contact information will be provided after publication of the primary study results. How to obtain: Requests will be reviewed by the research team. After scientific and ethical approval, a data use agreement will be completed and access to de-identified data will be provided. Comments:
public Akram Jafari
Rahmatieh, Islamic Azad University Shahrekord Branch
Shahrekord Iran (Islamic Republic of) 8817630003 +98 38 3336 1001 jafari.akm@gmail.com Islamic Azad University scientific Akram Jafari
Rahmatieh, Islamic Azad University Shahrekord Branch
Shahrekord Iran (Islamic Republic of) 8817630003 +98 38 3336 1001 jafari.akm@gmail.com Islamic Azad University Iran (Islamic Republic of) Participants will be men and women aged 30-60 years with imaging-confirmed nonalcoholic fatty liver disease; body mass index will be 25-40 kg/m2; body-weight variation during the preceding 3 months will be less than 3%; type 2 diabetes will be absent; glucose-lowering medication will not be used; regular structured resistance training during the preceding 6 months will be absent; omega-3 supplementation during the preceding 8 weeks will be absent; and medical clearance for progressive resistance exercise will be required. 30 years 60 years Both Participants with viral hepatitis, autoimmune liver disease, hemochromatosis, Wilson disease, clinically established cirrhosis or another chronic liver disease, habitual alcohol intake >20 g/day in women or >30 g/day in men, pregnancy or lactation, unstable cardiovascular disease, clinically significant renal disease, neuromuscular or musculoskeletal disorders preventing safe resistance exercise, use of medications known to induce hepatic steatosis, clinically relevant bleeding disorders, or current participation in another structured exercise or intentional weight-loss program will be excluded. Treatment - Other Treatment - Other Treatment - Other Placebo Resistance training plus omega-3: Participants will complete a 12-week supervised whole-body progressive resistance-training program three times per week on nonconsecutive days, with 36 scheduled sessions. They will consume four omega-3 softgels daily, providing 1.44 g/day EPA and 0.96 g/day DHA. Resistance training plus placebo: Participants will complete the same 12-week supervised progressive resistance-training program three times per week on nonconsecutive days, with 36 scheduled sessions. They will consume four externally matched corn-oil placebo softgels daily. Omega-3 without structured resistance training: Participants will consume four omega-3 softgels daily for 12 weeks and will maintain habitual physical activity without initiating structured resistance training. Placebo without structured resistance training: Participants will consume four externally matched corn-oil placebo softgels daily for 12 weeks and will maintain habitual physical activity without initiating structured resistance training. HOMA-IR at week 12, adjusted for baseline HOMA-IR. Timepoint: Baseline and after 12 weeks. Method of measurement: Fasting plasma glucose and fasting serum insulin will be measured. HOMA-IR will be calculated as fasting insulin multiplied by fasting glucose divided by 22.5. Circulating irisin. Timepoint: Baseline and after 12 weeks. Method of measurement: Serum irisin will be quantified using a human irisin ELISA kit; samples will be assayed in duplicate. Circulating myostatin. Timepoint: Baseline and after 12 weeks. Method of measurement: Serum myostatin will be quantified using a human GDF-8/myostatin immunoassay; samples will be analyzed in duplicate. Plasma malondialdehyde. Timepoint: Baseline and after 12 weeks. Method of measurement: Plasma malondialdehyde will be quantified by high-performance liquid chromatography with fluorescence detection. Fasting triglycerides. Timepoint: Baseline and after 12 weeks. Method of measurement: Fasting serum triglycerides will be analyzed on an automated biochemical analyzer using a glycerol-phosphate oxidase/peroxidase method. Serum alanine aminotransferase. Timepoint: Baseline and after 12 weeks. Method of measurement: Serum alanine aminotransferase will be analyzed on an automated biochemical analyzer using an IFCC-compatible kinetic method. Controlled attenuation parameter. Timepoint: Baseline and after 12 weeks. Method of measurement: Hepatic steatosis will be quantified using vibration-controlled transient elastography with controlled attenuation parameter; at least 10 valid acquisitions will be obtained and the median will be retained. Islamic Azad University Approved 2026-05-10 Ethics Committee of Islamic Azad University, Shahrekord Branch Rahmatieh, Islamic Azad University Shahrekord Branch Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)