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IRCT20230821059213N1 IRCT 2023-09-06 Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition The effect of time-restricted feeding (TRF) combined with a Lacto-Ovo-Vegetarian (LOV) diet on controlling of non-alcoholic fatty liver disease 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 2023-08-23 anticipated 46 Complete https://irct.ir/trial/72231 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 3 Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Receiving a 3-month diet plan based on the personal energy requirement calculated according to the Mifflin formula and in the form of a combination of the 16:8 time-restricted feeding method, in which food intake is limited to an 8-hour period, followed by a 16-hour fasting period (for example, 8 pm to 12 noon) According to the fact that during the 16-hour fasting, it is free to drink non-caloric substances such as water, coffee and tea; And the lacto-ovo-vegetarian diet, in which the consumption of red meat, poultry, fish, and other products containing this group of foods is not allowed in this diet. Intervention 2: Control group: Receiving nutritional recommendations for disease control such as: Avoiding excessive consumption of sugar, jam, honey, syrup, soft drinks and other foods that contain sugar and alcoholic beverages. Avoiding high consumption of high-fat foods, oil and fried foods. And also Eating a variety of vegetables with meals. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mahshad Shafiee
School of Nutrition Sciences & Food Technology., Hafezi Ave., Farahzadi Blvd., Qods town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 mahshadshafiee97@gmail.com Shahid Beheshti University of Medical Sciences scientific Atousa Saeidpour
School of Nutrition Sciences & Food Technology., Hafezi Ave., Farahzadi Blvd., Qods town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 atoosa.saidpour@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Body mass index higher than 24.9 (BMI≥25) Having evidence of steatohepatitis and non-alcoholic fatty liver based on the confirmation of the attending physician and the patient's laboratory and ultrasound results Not having a history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men Willingness to participate in the study and ability to complete the study process 18 years no limit Both Having other chronic and acute liver diseases and disorders (hepatitis B, C, etc.), biliary disease, kidney diseases, endocrine disorders, confirmed autoimmune diseases, cancer and hereditary disorders affecting the liver (iron and copper storage disease) Having uncontrolled cardiovascular diseases, chronic inflammatory disease, diabetes and celiac disease Alcoholism or drug abuse Pregnancy or Lactation in women Consumption of hepatotoxic drugs such as phenytoin, amoxifen and lithium Consumption of fiber, omega-3 and antioxidant supplements during the last 3 months Consumption of weight loss drugs or supplements Following special weight loss diets during the last 3 months Losing more than 10% of body weight during the last 6 months Failure to accept study conditions K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Lifestyle Intervention group: Receiving a 3-month diet plan based on the personal energy requirement calculated according to the Mifflin formula and in the form of a combination of the 16:8 time-restricted feeding method, in which food intake is limited to an 8-hour period, followed by a 16-hour fasting period (for example, 8 pm to 12 noon) According to the fact that during the 16-hour fasting, it is free to drink non-caloric substances such as water, coffee and tea; And the lacto-ovo-vegetarian diet, in which the consumption of red meat, poultry, fish, and other products containing this group of foods is not allowed in this diet. Control group: Receiving nutritional recommendations for disease control such as: Avoiding excessive consumption of sugar, jam, honey, syrup, soft drinks and other foods that contain sugar and alcoholic beverages. Avoiding high consumption of high-fat foods, oil and fried foods. And also Eating a variety of vegetables with meals. Weight. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Scale. Fibrosis index (FIB-4). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation. Body Mass Index (BMI). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation. Fat Mass. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Bio Impedance Analyzer. Fat Free Mass. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Bio Impedance Analyzer. Fatty Liver Index (FLI). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation. BARD score. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation. AST to Platelet Ratio Index (APRI). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation. Serum lipid profile (total cholesterol, triglyceride, HDL-C, LDL-C). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample. Liver enzymes (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample. Serum Insulin and Fasting Blood Sugar (FBS). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample. Insulin sensitivity index (QUICKI) and Insulin resistance index (HOMA-IR). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation. Tumor necrosis factor alpha (TNF-α). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample. High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample. Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition Approved 2023-08-15 Ethics committee of Shahid Beheshti University of Medical Sciences School of Nutrition Sciences & Food Technology., Hafezi Ave., Farahzadi Blvd., Qods town Tehran Tehran Iran (Islamic Republic of)