Investigating the Effects of a Low Acid Load Diet and N-Acetylcysteine Supplementation on Hepatic Steatosis, Biochemical, Anthropometric, and Blood Pressure Indices in Patients with Non-Alcoholic Fatty Liver Disease

Determining the effect of low acid load diet and N-Acetylcysteine (NAC) supplementation on hepatic steatosis, biochemical, anthropometric and blood pressure indices in patients with non-alcoholic fatty liver disease (NAFLD)

Clinical trial with control group, parallel groups, single blind, on 66 patients, randomization based on the steatosis severity will be done using the website.

Eligible participants for the study will be recruited from individuals visiting the Liver and Gastrointestinal Clinic at Motahari Clinic. They will be randomly assigned to one of three groups. Participants will be referred to Imam Reza Clinic for anthropometric evaluations and will receive a diet along with supplement or a placebo. The participants will be blinded to their group.

Inclusion Criteria: Literate NAFLD patients aged 18-60, with a Controlled Attenuation Parameter (CAP) score ≥260 dB/m and Liver Stiffness Measurement (LSM) ≤9.4 kPa , 25 ≤ body mass index ≤ 35; receiving consistent treatment in participants suffering dyslipidemia or hypertension. Exclusion Criteria: Pregnancy, breastfeeding, other liver diseases, diabetes, kidney issues, or mental health disorders; alcohol consumption above 20 g/d (women) or 30 g/d (men); recent use of hormonal or weight-affecting medications; prior bariatric surgery; antioxidant supplementation ;hospitalization and infection in the past two weeks.

Participants in this study will be divided into two intervention groups and one control group. Group 1: 600 mg NAC (two tablets daily) + healthy diet. Group 2: Low acid load diet + two starch tablets daily. Group 3: Healthy diet + two starch tablets daily.

CAP score; LSM; Liver enzymes; Serum glutathione; Fasting blood sugar and insulin; Insulin resistance; Lipid profile; Anthropometric indices; Blood pressure

To ensure the integrity of the study, participants will be divided into three groups: two intervention groups and one control group. This division will be achieved using Stratified permuted block randomization , based on two levels of hepatic steatosis severity (moderate and severe), as determined by the CAP score obtained from FibroScan results. The allocation will utilize a reliable online tool for randomization, accessible at: https://www.sealedenvelope.com/simple-randomiser/v1/lists Once the random allocation sequence is established, the groups will be labeled with conventional names: A, B, and C. These names will be placed in sealed envelopes according to the predetermined sequence, which will be numbered sequentially. After participants enter the study and complete their initial assessments, a sealed envelope corresponding to their order of entry will be opened. This envelope will contain the assigned group's conventional name, which was determined by an external party not involved in the study. This method ensures that the allocation sequence remains concealed from the research team, maintaining the blinding necessary for unbiased implementation.

In this study, two main interventions, one in the form of diet and the other in the form of supplements, are presented to the patients. Since designing and presenting the diet and teaching it to the patient is the responsibility of the principal investigator , and it is not possible to blind the trainer, the present intervention will be performed in a single blind manner. At the outset of the study, the principal investigator will coordinate with participants, oversee the study's implementation, and gather baseline data. Throughout the intervention, the principal investigator will engage in various activities, including making phone calls, monitoring diet and physical activity, sending text messages, and conducting face-to-face meetings with participants. Following the completion of the intervention, the principal investigator will also assess anthropometric indicators. Finally, the principal investigator will be responsible for the final data collection, statistical analysis, and preparation of the final report.