Evaluation of the effects of Fasting Mimicking Diet (FMD) Combined with a Low-Sugar Diet on lipid profile, glycemic, inflammatory and histologic indices in Non-Alcoholic Fatty Liver (NAFLD): a randomized control trial

Determining the effect of fasting diet (5: 2) and 8.16 fasting diet combined with a Low-Sugar Diet in comparison with the control group on some metabolic factors, inflammation, steatosis and liver fibrosis in patients with non-alcoholic fatty liver

Randomized clinical trials with control groups, parallel groups are performed on 75 patients

In this study, adults with non-alcoholic fatty liver disease referred to liver clinic of Taleghani hospital, who have the criteria to enter the study, if they desire to participate in this research fill out general and activity questionnaires and anthropometric indicators are collected. At the beginning and end of the study, fibroscan and blood tests are performed to evaluate the indicators

People who desire to participate in the study; age 18-50 years; BMI above 25 who have evidence of non-alcoholic steatohepatitis in ultrasound or fibroscan; no history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men; absence of other chronic and acute liver diseases and disorders, biliary tract disease, autoimmune diseases, cancer and hereditary disorders affecting Liver status and liver cirrhosis, lack of pregnancy or lactation in women; no use of hepatotoxic drugs are included in the study. If they do not want to continue studying or using hepatotoxic drugs during the study or non-compliance with the diet, they are excluded.

1- Control 2-fasting diet (5 /2) 3- intermittent-fasting diet 8/16 combined with a Low-Sugar Diet

Hepatic fibrosis, and steatosis Lipid profile, Glycemic indices, Liver enzymes, Inflammatory factors

Update the variables

The first step is to create a random sequence number. For this purpose, we will use a random number generator on Stattrek (https://stattrek.com/statistics/random-number-generator.aspx) for 75 numbers range from 1 to 3 (for example: 2 1 3 1 2 1 2 1 1 3 3 3 3 2 2 3 2 3 1 1 2 2 3 3 1 2 2..............).Then, we will specify the numbers to the groups for example, 1 will be assigned to the intervention group one (fasting diet 2/5), the numbers 2 to the intervention group two (fasting diet 8/16 combined with a low-sugar ediet ), the numbers 3 to the control group. Each number will represent a group according to the defined numbers. With this method, we will have a specific sequence of 75 codes of 1, 2, 3 , which shows the first to seventy-fifth people who are going to be entered in the study in each group. We write the codes on a piece of paper and put them in an envelope to use during sampling. Thus, after reviewing the inclusion criteria and if the participants desire, we will enter each person included in the study according to our predetermined list.