The Effects of Acupuncture with Weight Loss Diet on Metabolic Parameters in Patients with Non-Alcoholic Fatty Acid Liver: Randomized Controlled Single-Blinded Clinical Trial

The effects of acupuncture with a weight loss diet on metabolic status in patients with NAFLD

The clinical trial is a phase 3, single-blind, controlled (sham) study with 60 patients. Randomization will be conducted using RAS software.

The study will be conducted on 60 eligible volunteers for 8 weeks. Sampling will be done through announcements at the Ahmadieh Centeor through referrals from gastroenterology specialists. Patients will be randomly assigned (using RAS software) and will be followed for eight weeks. The individuals in both groups will be matched for age, gender, and NAFLD grade. Additionally, all participants will be monitored by a nutrition specialist. Diet will consist of 50% carbohydrates, 20% protein, and 30% fat, with a calorie deficit of 500 kcal from the total energy needs calculated for each individual. Blinding for patients will be achieved through sham treatment.

Inclusion Criteria: Both sexes NAFLD with grades 2 or 3 Age range: 20-65 years Exclusion Criteria: Individuals with chronic thyroid disorders, autoimmune disorders, various malignancies, and liver diseases other than non-alcoholic fatty liver disease, including types of hepatitis (A, B, C), Wilson's disease, Crohn's disease, uncontrolled diabetes, and hemochromatosis Pregnant or breastfeeding women

1.Intervention Group: Acupuncture with a weight loss diet. 2.Control (Sham) Group: Sham acupuncture with a weight loss diet.

Liver Fatty Grade, Liver Enzymes (Aspartate Aminotransferase, Alanine Aminotransferase), Weight and Body Mass Index, Fasting Blood Sugar, Total Cholesterol, Triglycerides , LDL Cholesterol, HDL Cholesterol

In order to allocate participants to the two study arms (intervention and control groups), simple randomization will be used. This method is designed to ensure a fair and unbiased distribution of participants between the groups and to reduce the impact of confounding factors. After screening and confirming eligibility for the study, a list of qualified participants will be created. Then, using the RAS software, a random sequence for allocating participants to the study groups will be generated. In this method, information regarding the number of groups and sample size is input into the software, which then generates random numbers accordingly. The output is a list equal to the sample size, divided into the two groups. Therefore, the allocation of individuals to one of the two groups will be completely random and unpredictable. Based on this list, it will be determined whether an individual entering the study is placed in the acupuncture group or the control group. The allocation of individuals to one of the two study groups is concealed, and participants are unaware of their assigned group. After generating the random chain in the software, qualified individuals are assigned a code from 1 to 60 based on their entry time into the study. Based on the pre-established sequence and the individual’s code, it will be determined which group they are allocated to

Acupuncture is performed at sites other than the treatment points for fatty liver in the sample group

confidentiality