The effect of time-restricted feeding (TRF) combined with a Lacto-Ovo-Vegetarian (LOV) diet on anthropometric indices, body composition, hepatic parameters, glucose homeostasis, lipid profile and inflammatory biomarkers in overweight and obese patients with non-alcoholic fatty liver disease: a Randomized Control Trial

Determining the effect of combined administration of Time-Restricted Feeding (TRF 16:8) and Lacto-Ovo-Vegetarian diet on anthropometric indices, body composition, liver parameters, glucose homeostasis, lipid profile and inflammatory factors in overweight and obese patients with non-alcoholic fatty liver disease

This study is a randomized clinical trial with a control group, with parallel groups, phase 3 on 46 patients, and random sequence software will be used for randomization.

In this study, among the patients with non-alcoholic fatty liver disease who referred to the Gastroenterology and Liver Clinic of Taleghani Hospital and their disease was confirmed by a specialist doctor, 46 people who have the inclusion criteria will be selected randomly and will be placed in the intervention group or control group. At the beginning and end of the study, blood samples will be taken from the participants and anthropometric parameters and body composition will be measured. After that, people will receive a diet plan or nutritional advice for a period of 3 months based on their group.

Inclusion criteria: age over 18 years, body mass index over 24.9, evidence of non-alcoholic steatohepatitis. Exclusion criteria: Pregnancy and lactation, history of receiving a diet plan or weight loss in the last 3 months, alcoholism, suffering from other chronic diseases such as liver, kidney, endocrine and cardiovascular diseases.

1. Intervention: receiving a Lacto-Ovo-Vegetarian diet combined with the time-restricted feeding method [16:8] (16 hours fasting and 8 hours receiving a Lacto-Ovo-Vegetarian diet) 2. Control: receiving nutritional recommendations to control the disease

Weight and body mass index, liver fibrosis, lipid profile, liver enzymes, inflammatory factors (hs-CRP, TNF-α)

The first step is to create a random sequence number. For this purpose, we will use a random number generator on Stat trek (https://stattrek.com/statistics/random-number-generator.aspx) for 50 numbers ranging from 1 to 2 (for example 2 1 1 2 1 2 1 1 2 2 2 1 1 2 2 1 2 2...).Then, we will specify the numbers to the groups, for example, 1 will be assigned to the intervention group, and the numbers 2 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 50 codes of 1, 2, which shows the first to 50th people who are going to be entered into 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.