The effect of moderate carbohyderate restriction diet on liver enzymes, steatosis and fibrosis in normal weight individuals with non-alcoholic fatty liver disease: a parallel randomized controlled clinical trials

Determining the effect of moderate carbohydrate restriction diet on liver enzymes, steatosis and fibrosis in normal weight individuals with non-alcoholic fatty liver disease

A clinical trial with a control group, parallel group, randomized groups, on 52 patients. lottery container was used for randomization.

A controlled clinical trial will be performed at the Gastroenterology Clinic. Before the intervention anthropometric and biochemical assessment, steatosis and liver fibrosis assessment by Fibro-scan will be done. Individuals will be randomly divided into intervention and control groups. The subjects in the intervention group will be received a moderate carbohydrate-restricted diet, which included 40-45% of energy from carbohydrates, 35-40% of energy from fat, and the rest of energy from a source of protein for 12 weeks. The control group will be received an isocaloric diet for 12 weeks. The diet will be included 50-55% of energy from carbohydrates, 25-30% from fat, and the rest of energy from a source of protein.

Inclusion criteria: 1.Body mass index between 18.5-25 kg/m2, 2. Aged 18-65 years, 3.Patients with non-alcoholic fatty liver disease. Non-inclusion criteria: 1.Consuming alcohol, 2.Pregnancy and breastfeeding 3. Suffering from other liver diseases, 4. Drug and tobacco use, 5. Consuming corticosteroids during the last three months, 6. Follow a weight loss diet during the last three months.

Intervention group: intake of moderate carbohydrate restriction diet Control group: intake of isocaloric diet

Steatosis and liver enzymes including ALT, AST and GGT.

According to the formula and considering the possible drop-out, we will be need 52 participants and 68 participants have been registered incorrectly. In the exclusion criteria section, according to the covid-19 pandemic and the individual's desire to use multivitamins to maintain and improve the immune system, we will include individuals who consume multivitamins and minerals. In the primary and secondary outcomes section, considering that the duration of the intervention to investigate liver fibrosis is short, we will consider liver fibrosis as a secondary outcome.

Individuals will be classified based on age, gender (male/female) and BMI (±2) into different blocks. To do randomization, an identification code will be given to each participant, and then the codes of each two participants with the same age, gender and BMI will be poured into the lottery container. Random allocation will be done by a person who is unaware of the study. The first code will be assigned to the intervention group, the second code to the control group and so other participants will be randomly assigned to the two groups.