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

The aim of this study was to investigate the effect of an 8-week combined intervention of aerobic exercise and vitamin D supplementation on metabolic variables and oxidative stress, health-related quality of life (HRQoL), and psychological disorders in patients with non-alcoholic fatty liver disease (NAFLD) of different grades.

A randomized, controlled, single-blind, parallel-group clinical trial on the diet of women with nonalcoholic fatty liver disease of different grades.

This research will be conducted in the city of Tuyserkan. First, the research variables will be measured. Then, 6 groups of participants in the research will receive the desired interventions. After the interventions are completed, the research variables will be measured again. In this research, participants will be blinded. Tablets similar to vitamin D tablets will be used as placebo.

Women with non-alcoholic fatty liver disease (NAFLD) between the ages of 45 and 65, confirmed diagnosis of NAFLD based on ultrasound findings, no significant weight loss or gain (more than 5% of body weight) in the last three months, no other liver disease, no bariatric surgery

Group 1: Patients with grade 1 fatty liver + aerobic exercise + vitamin D supplementation Group 2: Patients with grade 2 fatty liver + aerobic exercise + vitamin D supplementation Group 3: Patients with grade 3 fatty liver + aerobic exercise + vitamin D supplementation Control group: Patients with fatty liver (grade 1) without exercise and receiving placebo Control group: Patients with fatty liver (grade 2) without exercise and receiving placebo Control group: Patients with fatty liver (grade 3) without exercise and receiving placebo

liver enzymes, lipid profile, inflammation, oxidation .improvement in quality of life

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.

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.

All data can be shared after de-identifying the subjects

6 9 months after results are published

It will only be available to researchers working in academic and scientific institutions

All data can be used for citation

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

In case of formal request, stating the relevant reasons and providing full details, the data will be sent via email after 72 hours