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IRCT20251127068131N1 IRCT 2025-12-05 Razi University Investigating the Effects of an 8-Week Combined Aerobic Exercise and Vitamin D Supplementation in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) Across Different Grades Investigating the Effects of an 8-Week Combined Aerobic Exercise and Vitamin D Supplementation Program on Metabolic Variables, Oxidative Stress, Health-Related Quality of Life (HRQoL), and Psychological Disorders (Depression, Anxiety, and Sleep Disorders) in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) Across Different Grades 2026-01-05 anticipated 48 Complete https://irct.ir/trial/87793 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the block randomization method will be used through the website www.randomization.com. For this purpose, each subject is first assigned a number as a unique identification code and a 48-digit sequence (equal to the sample size) is created. Then, the names of the intervention groups, including 1) Group 1: Patients with Grade 1 fatty liver + aerobic exercise + vitamin D supplementation, 2) Group 2: Patients with Grade 2 fatty liver + aerobic exercise + vitamin D supplementation, 3) Group 3: Patients with Grade 3 fatty liver + aerobic exercise + vitamin D supplementation, 4) Control group: Patients with fatty liver (Grade 1) without exercise and receiving placebo, 5) Control group: Patients with fatty liver (Grade 2) without exercise and receiving placebo, and 6) Control group: Patients with fatty liver (Grade 3) without exercise and receiving placebo; will be defined in the relevant section on the website. After defining the groups and in order to prevent potential problems caused by blocking with fixed-sized blocks, a random selection method of blocks of different sizes will be used for blocking. In this case, given the sample size, the block sizes will be unequal and a multiple of the number of intervention groups (e.g., 4 or 8). The website has the ability to randomly generate sequences of blocks of different sizes. In the final step, by executing the Generate Plan command on the website, using the number (code) assigned to each subject and examining the blocks, the group of each subject will be determined, Blinding description: The present study will be conducted in a single-blinded manner and participants will be kept blind to the vitamin D or placebo intake, while due to the nature of exercise training, blinding will not be done in this case (exercise intervention). In order to blind the three groups that do not receive vitamin D tablets, tablets similar to vitamin D tablets in terms of appearance, smell, taste and color will be used as placebo. For this purpose, both vitamin D and placebo will be placed inside capsules with completely identical appearance. Information regarding vitamin D and placebo intake will be kept secret from the subjects. N/A Non-alcoholic fatty liver in different grades. Intervention 1: Intervention group: In this group, people with grade 1 fatty liver will receive an aerobic exercise program consisting of 45-60 minute sessions at an intensity of 60-75% of maximum heart rate (MHR), three sessions per week for 8 weeks. This group will also receive 50,000 international units of vitamin D once a week. Intervention 2: Intervention group: In this group, people with grade 2 fatty liver will receive an aerobic exercise program consisting of 45-60 minute sessions at an intensity of 60-75% of maximum heart rate (MHR), three sessions per week for 8 weeks. This group will also receive 50,000 international units of vitamin D once a week. Intervention 3: Intervention group: In this group, people with grade 3 fatty liver will receive an aerobic exercise program consisting of 45-60 minute sessions at an intensity of 60-75% of maximum heart rate (MHR), three sessions per week for 8 weeks. This group will also receive 50,000 international units of vitamin D once a week. Intervention 4: Control group: In this group, people with grade 1 fatty liver will receive placebo pills, which are completely similar to vitamin D pills, daily for 8 weeks and will not do any exercise. Intervention 5: Control group: In this group, people with grade 2 fatty liver will receive placebo pills, which are completely similar to vitamin D pills, daily for 8 weeks and will not do any exercise. Intervention 6: Control group: In this group, people with grade 3 fatty liver will receive placebo pills, which are completely similar to vitamin D pills, daily for 8 weeks and will not do any exercise. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying the subjects When: 6 9 months after results are published To whom: It will only be available to researchers working in academic and scientific institutions Conditions: All data can be used for citation Where to obtain: If you need to receive documents, please send an email to Rastegar Hoseini, Head of the Research Team, at the email address: rastegar.hoseini@gmail.com and Maryam Al-Sadat Emami, executive researcher, at the email address: maryam.s.emami@gmail.com How to obtain: In case of formal request, stating the relevant reasons and providing full details, the data will be sent via email after 72 hours Comments:
public Rastegar Hosseini
Room 49, Faculty of Sport Sciences, Razi University, University َAvenue, Taq-e Bostan
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 rastegar.hoseini@gmail.com Razi University scientific Rastegar Hosseini
Room 49. Faculty of Sport Sciences, Razi University, University Avenue, Taq-e Bostan
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 rastegar.hoseini@gmail.com Razi University Iran (Islamic Republic of) Gender and Age: Participants must be women with non-alcoholic fatty liver disease (NAFLD) between the ages of 45 and 65. Diagnosis: The diagnosis of NAFLD must be confirmed based on ultrasound findings and patients are categorized into three grades (1, 2, and 3) 45 years 65 years Female No alcohol consumption: Participants should have no history of alcohol consumption (alcohol consumption less than 20 grams per day for women). Weight stability: Participants should not have had significant weight loss or gain (more than 5% of body weight) in the last three months. No other liver disease: Patients should not have viral hepatitis (such as hepatitis B and C), autoimmune hepatitis, hemochromatosis, drug-induced liver disease, Wilson's disease, or celiac disease. No bariatric surgery: Participants should not have a history of bariatric surgery (such as gastric bypass) K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Placebo Placebo Intervention group: In this group, people with grade 1 fatty liver will receive an aerobic exercise program consisting of 45-60 minute sessions at an intensity of 60-75% of maximum heart rate (MHR), three sessions per week for 8 weeks. This group will also receive 50,000 international units of vitamin D once a week. Intervention group: In this group, people with grade 2 fatty liver will receive an aerobic exercise program consisting of 45-60 minute sessions at an intensity of 60-75% of maximum heart rate (MHR), three sessions per week for 8 weeks. This group will also receive 50,000 international units of vitamin D once a week. Intervention group: In this group, people with grade 3 fatty liver will receive an aerobic exercise program consisting of 45-60 minute sessions at an intensity of 60-75% of maximum heart rate (MHR), three sessions per week for 8 weeks. This group will also receive 50,000 international units of vitamin D once a week. Control group: In this group, people with grade 1 fatty liver will receive placebo pills, which are completely similar to vitamin D pills, daily for 8 weeks and will not do any exercise. Control group: In this group, people with grade 2 fatty liver will receive placebo pills, which are completely similar to vitamin D pills, daily for 8 weeks and will not do any exercise. Control group: In this group, people with grade 3 fatty liver will receive placebo pills, which are completely similar to vitamin D pills, daily for 8 weeks and will not do any exercise. Liver enzymes (ALP, AST, ALT). Timepoint: During the pre-test and post-test phase (48 hours after the last training session). Method of measurement: Blood sampling, Use of ultrasound. Lipid profile (total cholesterol, triglycerides, HDL, LDL). Timepoint: During the pre-test and post-test phase (48 hours after the last training session). Method of measurement: Blood sampling. Inflammatory index (TNFα). Timepoint: During pre-test and post-test phase (48 hours after the last training session). Method of measurement: Blood sampling. ELISA method. Antioxidant index (SOD and MDA). Timepoint: During pre-test and post-test phase (48 hours after the last training session). Method of measurement: Blood sampling. ELISA method. Health-related quality of life. Timepoint: In the pre-test and post-test phase (48 hours after the last practice session). Method of measurement: using the SF-36 questionnaire. Depression. Timepoint: In the pre-test and post-test phase (48 hours after the last training session). Method of measurement: From the Beck Depression Inventory (BDI). Anxiety. Timepoint: In the pre-test and post-test phase (48 hours after the last training session). Method of measurement: Beck Anxiety Inventory (BAI). Sleep disorders. Timepoint: In the pre-test and post-test phase (48 hours after the last training session). Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Razi University Approved 2025-11-12 Ethics commitee of Razi University Razi University, University Avenue, Taq-e Bostan kermanshah Kermanshah Iran (Islamic Republic of)