Effect of zinc supplementation on serum zinc status, lipid profile, liver enzymes (ALT, AST), insulin resistance, inflammatory markers and oxidative stress in non-alcoholic fatty liver patients

The effect of zinc supplementation on serum zinc status, lipid profile, liver enzymes (ALT, AST), insulin resistance, inflammatory markers and oxidative stress in non-alcoholic fatty liver patients with zinc deficiency

A randomized, controlled, double-blind, placebo-controlled clinical trial

Patients were referred to Imam Reza clinic after being admitted to the test and then referred to Shahid Motahari clinic for blood sampling. The patient-level study and the outcome evaluator will be blinded.

Inclusion criteria: -Both sex (male and female) - Ages between 18 and 70 years -Attention to fatty liver confirmed by ultrasound - Not consuming alcoholic beverages - Lack of lipodystrophy - Lack of parenteral nutrition - No diseases that affect the bile and bile ducts - No severe weight loss 6 months ago Lack of congenital metabolic diseases - Not taking medications that cause fatty liver (methotrexate, tamoxifen, valproate, etc.) -No pregnancy and lactation - Lack of serum ALT levels more than 10 times the limit - No history of severe systemic diseases such as cardiovascular disease, kidney disease - No chemotherapy for the past year - No drug or alcohol poisoning - Not taking any supplements containing zinc Exclusion criteria: - Sensitivity to intervention supplements

Patients in the intervention group: Coated capsule containing 30 mg of zinc made in Nature made company Patients in the control group: The placebo will be prepared by the Faculty of Pharmacy of Shiraz University of Medical Sciences and will be identical in appearance, size, color, and so on.

Mean serum zinc; Liver enzymes (ALT, AST); Insulin resistance; hsCRP inflammatory factor; malondialdehyde; total antioxidant capacity, triglyceride, total cholesterol, HDL-cholesterol; LDL-cholesterol;

Samples were included in this study by simple randomization. In this way, patients were randomly assigned to one of the intervention and placebo groups after having met the inclusion criteria and obtaining written consent.That way the first patient in The intervention group and the next group are included in the control group.This is done until the end of the sample.

The patient-level study and the outcome evaluator will be blinded. Medication and placebo capsules are divided into two equal groups before filling on the basis of random number table by block method. Only a researcher based on the initial stored form of randomized results can decode the contents of each capsule. The person responsible for delivering the medication, the patient, the physician, and the outcome assessor will not be aware of the coding. The results of the intervention and control groups will be delivered to the statistical analyst under the titles of groups A and B.

All data is shared after unidentifiable people

Start of access period 6 months after printing results

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