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IRCT20100524004010N37 IRCT 2023-03-23 Shahid Beheshti University of Medical Sciences The effect of replacing lunch grains with quinoa in the diet in patients with NAFLD. The effect of replacing lunch grains with quinoa in the diet on anthropometric indicators, blood lipid composition, glycemic status, inflammatory markers, steatosis and liver fibrosis in patients with NAFLD. 2023-04-30 anticipated 42 Complete https://irct.ir/trial/68682 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study will be random and by Balanced Block Randomization method. The random sequence list will be designed and used by Excel software.Based on this list, the researcher places people in the intervention or control group. N/A Non-alcoholic fatty liver. Intervention 1: Intervention group: consumption of quinoa seeds for lunch instead of other grains and weight loss diet for 3 months. The amount of quinoa consumed for each person will be calculated based on the amount of energy needed by the person. A 24-hour feed record will be received for 3 days at the beginning and end of the study, including one holiday and two non-holiday days. Domestically grown white quinoa will be used. Intervention 2: Control group: weight loss diet for 3 months and receive weight loss 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 There is no further information
public Afsane GHolamrezayi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 afsane.rezayi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Afsane GHolamrezayi
West Arghavan, Shahrak Gharb
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2293 0824 afsane.rezayi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People with non-alcoholic steatohepatitis and Controlled Attenuation Parameter score more than 263 No history of alcohol abuse Absence of other diseases and chronic and acute liver disorders Absence of pregnancy, breastfeeding and menopause in women Not taking hepatotoxic drugs such as phenytoin, amoxifen and lithium Not having lost more than 8 percent weight in the last 6 months Blood pressure less than 140/90 mmHg No kidney disease Not using weight loss drugs No history of allergy to quinoa No history of cardiovascular diseases, diabetes and gastrointestinal disorders affecting absorption Absence of pituitary, thyroid disorders Willingness to participate in the study Not having clinically diagnosed psychiatric disorders that impair the patient's ability to provide written informed consent 18 years 50 years Both Taking medicine or supplements that can affect the results Failure to accept study conditions pregnancy K76.0 Fatty (change of) liver, not elsewhere classified N/A N/A Intervention group: consumption of quinoa seeds for lunch instead of other grains and weight loss diet for 3 months. The amount of quinoa consumed for each person will be calculated based on the amount of energy needed by the person. A 24-hour feed record will be received for 3 days at the beginning and end of the study, including one holiday and two non-holiday days. Domestically grown white quinoa will be used. Control group: weight loss diet for 3 months and receive weight loss diet Level of steatosis and liver fibrosis. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Fibroscan. Lipid profil. 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. Shahid Beheshti University of Medical Sciences Approved 2023-01-22 Ethics Committee of National Nutrition and Food Technology Research Institute (NNFTRI) #7, Shahid Hafezi Ave, Farahzadi Blvd, Shahrak Gharb Tehran Tehran Iran (Islamic Republic of)