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IRCT20100524004010N31 IRCT 2020-08-19 Shahid Beheshti University of Medical Sciences 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 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 2020-09-22 anticipated 75 Complete https://irct.ir/trial/49958 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 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. N/A Nonalcoholic fatty liver disease. Intervention 1: Control group: Dietary recommendations. Intervention 2: Intervention group: fasting diet (5 days of normal diet and two consecutive days with 75% calorie restriction and permission to consume 25% of calories per person at a specific time, for example 12 to 16 am because it is easier to tolerate fasting). Intervention 3: Intervention group combined with a Low-Sugar Diet : fasting diet 8/16: 16 hours a day in fasting diet for example 8 nights to 12 noon and 8 hours normal diet Combined with a Low-Sugar Diet. 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 We have not yet decided how to share the final data
public Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) General desire to participate in the study Age 50-30 years - Has evidence of non-alcoholic steatohepatitis and CAP score more than 263 Body mass index (BMI) ≥ 25kg / m2 No history of alcohol consumption Lack of other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseases and hereditary disorders affecting the condition of the liver (iron, copper and ... ) No pregnancy or breastfeeding in women Do not take hepatotoxic drugs such as phenytoin, amoxifen and lithium Do not take antibiotics for more than a week during or before the study period Do not consume Milk thistle(Silybum marianum) Lack of chronic inflammatory disease No history of cancer Lack of treatment with anti-inflammatory drugs Lack of recent weight loss diet Blood pressure less than 90/160 mmHg No kidney disease (GFR greater than 60 or creatinine between 7-1.4) No weight loss of more than 8% in the last 6 months Do not use weight loss drugs (chemical drugs and effective herbal products) 18 years 50 years Both Changes in medications (lipid-lowering drugs, blood sugar control drugs, and blood pressure medications) during the study period Lack of adherence to the diet given to patients Take supplements or substances that change the individual effect of the diet during the intervention. K75.81 Nonalcoholic steatohepatitis (NASH) Lifestyle Lifestyle Lifestyle Control group: Dietary recommendations Intervention group: fasting diet (5 days of normal diet and two consecutive days with 75% calorie restriction and permission to consume 25% of calories per person at a specific time, for example 12 to 16 am because it is easier to tolerate fasting) Intervention group combined with a Low-Sugar Diet : fasting diet 8/16: 16 hours a day in fasting diet for example 8 nights to 12 noon and 8 hours normal diet Combined with a Low-Sugar Diet Hepatic steatosis, Liver fibrosis. Timepoint: At the first and at the 12th week of the study. Method of measurement: fibroscan. Weight. Timepoint: At the first and 12th week of the study. Method of measurement: Scale. BMI. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate. Waist to hip ratio. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate. Liver enzymes (AST,ALT,GGT). Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method. Lipid profile (TG,Total cholesterol,LDL-C,HDL-C). Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method. FBS. Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method. Insulin. Timepoint: At the first and 12th week of the study. Method of measurement: Radioimmunoassay. Hs-CRP. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA. CK-18. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA. HOMA-IR. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate. TAC. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA. Shahid Beheshti University of Medical Sciences Approved 2020-11-14 Ethics Committee of the National Institute of Nutritional Research and Food Industry No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)