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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251127068131N1

Enrollment

Registered

2025-12-05

Start date

2026-01-05

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver in different grades. Fatty (change of) liver, not elsewhere classified

Interventions

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 hea

Eligibility

Sex/Gender

Female

Age

45 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
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 (TNFa). 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.	—

Measure

Time frame

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 (TNFa). 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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRastegar Hosseini

Razi University

rastegar.hoseini@gmail.com+98 83 3845 8428

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026