The effect of L-arginine supplementation on matabolic factors and stress oxidative indices in patients with Metabolic dysfunction-associated steatotic liver disease (MASLD): a double-blind randomized controlled clinical trial

The effect of L-arginine supplementation on matabolic factors and stress oxidative indices in patients with Metabolic dysfunction-associated steatotic liver disease (MASLD)

Randomized clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 to 3 on 44 patients, RAS software was used for randomization.

This study is a randomized double-blind controlled clinical trial on patients with metabolic disorder associated with steatotic liver disease (MASLD) referred to Razi Hospital and specialized clinics affiliated to Tehran University of Medical Sciences, which in a time interval It will be held in the fall of 2023 to the summer of 2024 in Tehran. Patients will be included in the study after being diagnosed by a specialist doctor from the Gastroenterology Clinic of Razi Hospital in terms of inclusion and non-inclusion criteria.

Inclusion criteria: Patients with metabolic disorders associated with diagnosed steatotic liver disease without fibrosis and cap score below 310 and Metavir score below f1, which has been approved by a gastroenterologist, age 30-55, BMI 25-35, both Exclusion criteria: Pregnancy, breastfeeding having history of malignancy, kidney stones, other chronic and inflammatory diseases. Taking antibiotics, antivirals and antifungals Use of antioxidants and omega3 in the last 3 months Any history of alcohol and tobacco use

3000 mg L-arginine for 8 weeks, Placebo

Alanine transaminase, Aspartate aminotransferase, Low density lipoprotein, High density lipoprotein, Triglyceride, Total cholesterol, Fasting blood sugar, Fasting blood insulin, Malondialdehyde, Homeostatic Model Assessment for Insulin Resistance, Homeostasis Model Assessment of β-cell function, Quantitative insulin sensitivity check index

All subjects and researchers and healthcare personnel who are responsible for the care of patients will be unaware of the existing grouping until the end of the study; In such a way, the researcher and the person who takes the sample, like the study participants, are unaware of which patient will receive the vitamin pill or the placebo. Patients are also unaware of the type of pill received. Drugs and placebos are coded by a person who is completely unaware of the study process, and this code is placed in an envelope that indicates whether it is a drug or a placebo code. One group will receive drug A and one group will receive drug B. Also, pills containing L-arginine and placebo, which have the same color, smell, and size as the vitamin pill, will be given to the study subjects every 4 weeks by another person who has no knowledge of the research process. Hence, this study will be a double-blind study. Placebo tablets contain starch and are completely similar to L-arginine tablets in terms of color, appearance and smell. Placebo tablets are also prepared by the same company that manufactures L-arginine.

All subjects and researchers will be unaware of the existing grouping until the end of the study, and L-arginine supplement and placebo will be given to subjects once every 4 weeks by another person who has no knowledge of the research process. In order to evaluate the acceptance of the patients, a checklist will be prepared and given to the patients and they will be asked to record their daily consumption in it. In addition, in order to ensure the consumption of supplements, reminder messages will be sent to all patients every da