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IRCT20250527065918N1 IRCT 2025-08-31 Gonabad University of Medical Sciences The Effect of Sumac and a Low-Calorie Diet on Improving Fatty Liver Disease Comparison of the effects of Sumac supplementation plus calorie-restricted diet versus calorie-restricted diet alone on inflammatory markers, oxidative stress, and fasting blood glucose in patients with Non-Alcoholic Fatty Liver Disease (NAFLD) 2025-09-21 anticipated 62 Complete https://irct.ir/trial/83854 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To allocate participants into the intervention group (receiving sumac supplement) and the control group (receiving placebo), stratified block randomization will be used. Stratification will be based on body mass index (BMI: <30 or ≥30 kg/m²) and gender (male or female) to ensure balanced distribution within each stratum. A list of eligible participants will be prepared, and each individual will be categorized into one of four strata: female with BMI<30, female with BMI≥30, male with BMI<30, and male with BMI≥30. Then, within each stratum, participants will be randomly assigned to either group using Randomization.com (available at: https://www.randomization.com) with a block size of 4. The randomization list will only be accessible to the researcher responsible for allocation, Blinding description: To ensure proper blinding, the supplement and placebo will be identical in color, size, and odor, and neither the participants nor the researchers except for the pharmacist will be aware of their contents until the end of the study. 3 Non alcoholic fatty liver. Intervention 1: Intervention group: 1500 mg of Sumac powder supplement daily in three divided doses of 500 mg for 12 weeks. Intervention 2: Control group: 500 mg daily of placebo (corn starch) with a color and odor similar to sumac, daily in three divided doses of 500 mg for 12 weeks. Yes - There is a plan to make this available What will be shared: After completion of the study and publication of the results, the raw data will be made available to interested researchers upon request. Access will be provided through direct contact with the corresponding author and subject to approval by the ethics committee. When: After the project is completed (6 months after the results are published) To whom: Only for researchers working in academic institutions Conditions: People working in research centers. Where to obtain: Sending request to email: nattagh.elyas@gmail.com How to obtain: A maximum of 30 working days Comments:
public Elyas Nattagh Eshtivani
Mehdizadeh Blv
Gonabad Iran (Islamic Republic of) 9691874359 +98 51 5722 5027 nattagh.elyas@gmail.com Gonabad University of Medical Sciences scientific Elyas Nattagh Eshtivani
Mehdizadeh Blv
Gonabad Iran (Islamic Republic of) 9691874359 +98 51 5722 5027 nattagh.elyas@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Individuals aged 20 to 60 years Presence of fat accumulation in liver ultrasound evaluation with Grade 2 fatty liver and elevated liver enzymes (ALT and AST > 40) Ability to read and write Body Mass Index (BMI) greater than 25 kg/m² 20 years 60 months Both Having chronic lung diseases, other liver diseases, heart conditions, and any chronic kidney or digestive disease History of drinking alcoholic beverages Smoking and drug abuse Use of diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs), estrogen, tamoxifen, corticosteroids, and blood sugar-lowering drugs within 3 weeks before the start of the study and during the study Evidence of viral hepatitis infection Pregnancy Breast feeding Follow of special diet Regular consumption of antioxidant supplements such as vitamins E, C, and silymarin K75 Other inflammatory liver diseases Treatment - Other Placebo Intervention group: 1500 mg of Sumac powder supplement daily in three divided doses of 500 mg for 12 weeks Control group: 500 mg daily of placebo (corn starch) with a color and odor similar to sumac, daily in three divided doses of 500 mg for 12 weeks Oxidative stress status (MDA). Timepoint: Initially and 12 weeks (84 days) after starting sumac supplementation. Method of measurement: ELISA Kit. Blood glucose. Timepoint: Initially and 12 weeks (84 days) after starting sumac supplementation. Method of measurement: Biochemical kit. C reactive protein. Timepoint: Initially and 12 weeks (84 days) after starting sumac supplementation. Method of measurement: ELISA Kit. Tumor Necrosis Factor alpha (TNF-α). Timepoint: Initially and 12 weeks (84 days) after starting sumac supplementation. Method of measurement: ELISA Kit. Interleukin 10 (IL-10). Timepoint: Initially and 12 weeks (84 days) after starting sumac supplementation. Method of measurement: ELISA Kit. Total antioxidant capacity (TAC). Timepoint: Initially and 12 weeks (84 days) after starting sumac supplementation. Method of measurement: ELISA Kit. Alanine aminotransferase. Timepoint: Initially and 12 weeks (84 days) after starting sumac supplementation. Method of measurement: Biochemical kit. Aspartate aminotransferase. Timepoint: Initially and 12 weeks (84 days) after starting sumac supplementation. Method of measurement: Biochemical kit. Gonabad University of Medical Sciences Approved 2025-01-18 Research Ethics Committee of Gonabad University of Medical Sciences Mehdizadeh boulevard Gonabad Razavi Khorasan Iran (Islamic Republic of)