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IRCT20100524004010N36 IRCT 2023-03-14 Shahid Beheshti University of Medical Sciences Evaluation of the Combined Effects of Flaxseed Consumption and Fasting Mimicking Diet (FMD) on Patients with Non-Alcoholic Fatty Liver Diseases (NAFLD): a Randomized Control Trial Evaluation of the Combined Effects of Flaxseed Consumption and Fasting Mimicking Diet (FMD) on Anthropometric Indices, Blood Lipid Composition, Glycemic Control, Inflammatory Markers, Steatosis and Hepatic Fibrosis in Patients with Non-Alcoholic Fatty Liver Diseases (NAFLD): a Randomized Control Trial 2023-03-12 anticipated 100 Complete https://irct.ir/trial/68377 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 100 patients with non-alcoholic fatty liver, over 18 years of age, were randomized for 12 weeks by the simple randomized method according to the table of four random numbers and after stratification for BMI (1-range 25 to 29 and 2 - 30 and above) in four groups: 1- Control (nutritional recommendations to control the disease) 2- 16:8 fasting-mimicking diet: 16 hours a day in a fasting-mimicking mode and 8 hours of the usual diet. 3- Consumption of flaxseed (nutritional recommendations for disease control) 4- 16:8 fasting-mimicking diet + flaxseed consumption: 16 hours a day in a fasting-mimicking mode and 8 hours of usual diet plus the consumption of flaxseed. 2-3 Non-alcoholic fatty liver. Intervention 1: The first intervention group: (Fasting mimicking diet 16/8): the people were given nutritional recommendations to control the disease and a person is in a fasting mimicking mode for 16 hours a day. Intervention 2: The second intervention group (consumption of flaxseed): the people were given nutritional recommendations to control the disease and they consumed 30 grams of flaxseed daily in 8 hours that are not fast. Intervention 3: The third intervention group (fasting mimicking diet 16/8 + flaxseed consumption): the people were given nutritional recommendations to control the disease, and the person was in a fasting mimicking mode for 16 hours a day and 8 hours of the usual diet plus the consumption of flaxseeds. Intervention 4: Control group: They follow the nutritional recommendations to control the disease. 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) Age over 18 years Having evidence of non-alcoholic steatohepatitis and CAP score over 263 Not having a history of alcohol and drug abuse Absence of other chronic and acute liver disorders No use of chemical and herbal medicines that affect the liver and weight Not having a chronic inflammatory disease and no history of cancer No treatment with anti-inflammatory drugs, corticosteroids and hormones Not having lost more than 8 percent of the weight in the last 6 months Blood pressure less than 140/90 mmHg Not having uncontrolled kidney disease, pituitary disorders, thyroid, cardiovascular diseases, diabetes and digestive system disorders that affect absorption No history of excessive consumption of flaxseed Not having clinically diagnosed psychiatric disorders that impair the patient's ability to provide written informed consent Willingness to participate in the study 18 years no limit Both Having clinically diagnosed psychiatric disorders that impair the patient's ability to provide written informed consent Use of other supplements Unwillingness to participate in the study K76.0 Fatty (change of) liver, not elsewhere classified N/A N/A N/A N/A The first intervention group: (Fasting mimicking diet 16/8): the people were given nutritional recommendations to control the disease and a person is in a fasting mimicking mode for 16 hours a day. The second intervention group (consumption of flaxseed): the people were given nutritional recommendations to control the disease and they consumed 30 grams of flaxseed daily in 8 hours that are not fast. The third intervention group (fasting mimicking diet 16/8 + flaxseed consumption): the people were given nutritional recommendations to control the disease, and the person was in a fasting mimicking mode for 16 hours a day and 8 hours of the usual diet plus the consumption of flaxseeds. Control group: They follow the nutritional recommendations to control the disease. Level of steatosis and liver fibrosis. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Fibroscan. Lipid profile. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Insulin sensitivity index. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: math formula. Insulin resistance index. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: math formula. Insulin concentration. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Anthropometric indices. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: Tape measure, scale and mathematical formula. Blood pressure. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: Sphygmomanometer. High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Liver enzymes alanine transaminase, aspartate aminotransferase,gamma-glutamyl tansferase. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Serum glucose concentration. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. HbA1C. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Shahid Beheshti University of Medical Sciences Approved 2023-03-11 National Nutrition and Food Technology Research Institute (NNFTRI) #7, Shahid Hafezi Ave, Farahzadi Blvd, Shahrak Gharb Tehran Tehran Iran (Islamic Republic of)