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IRCT20240310061235N1 IRCT 2024-06-20 Yazd University of Medical Sciences Investigating the effect of high global quality of diet and artichoke supplement in non-alcoholic fatty liver disease Investigating the simultaneous effect of high global diet quality score and standard diet with and without artichoke supplementation on fasting blood sugar, lipid profile and liver function indices in patients with non-alcoholic fatty liver disease: a randomized clinical trial 2024-06-21 anticipated 100 Complete https://irct.ir/trial/76231 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: The random allocation between two groups will perform using Random allocation version 2 software. The random sequence will generate with this software using a simple random allocation method, and each number will allocate to an intervention group A or B. Allocation concealment will perform by calling or sending message to a third-person who is unaware of intervention, Blinding description: Participants, investigators and data collectors will be blinded to the study groups. Allocation concealment will perform by calling or sending message to a third-person who is unaware of intervention. N/A Patients with non-alcoholic fatty liver disease. Intervention 1: The first intervention group. Intervention 2: The second intervention group. Intervention 3: The third intervention group. Intervention 4: Control group:. Yes - There is a plan to make this available What will be shared: primary outcome will be available at the end of study When: 6 months after the results are published To whom: Academic institutions Conditions: Academic institutes can send their official request to the email of the scientific director of the project. the data will be sent after confirmation of ethics committee of shahid sadoughi university of medical sciences. It is not possible to perform statistical analysis on the data. Where to obtain: Sayyed Saeid Khayyatzadeh Assistant professor of nutrition in Shahid Sadoughi university of medical sciences Khayyatzadeh@yahoo.com 00983538209100 How to obtain: Academic institutes can send their official request to the email of the scientific director of the project. The data will be sent after confirmation of ethics committee of Shahid Sadoughi university of medical sciences Comments:
public Mona Jamalvandi
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
yazd Iran (Islamic Republic of) 8916188637 +98 35 3820 9100 m.jamalvandi71@yahoo.com Yazd University of Medical Sciences scientific Sayyed Saeid Khayyatzadeh
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
yazd Iran (Islamic Republic of) 8916188637 +98 35 3820 9100 khayyatzadeh@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age above 18 years Suffering from non-alcoholic fatty liver grade 1-3 18 years no limit Both Pregnancy or breastfeeding suffering from hepatitis, coronary, kidney, lung and thyroid diseases K76.0 Nonalcoholic fatty liver disease [NAFLD] Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group The second intervention group The third intervention group Control group: Fatty liver grade. Timepoint: The beginning and end of the study. Method of measurement: Ultrasound machine. Liver enzymes (ALT, AST). Timepoint: The beginning and end of the study. Method of measurement: Biochemical test. Fasting blood glucose. Timepoint: The beginning and end of the study. Method of measurement: Biochemical test. Lipid profile (LDL-c, HDL-c, TG). Timepoint: The beginning and end of the study. Method of measurement: Biochemical test. Weight. Timepoint: The beginning and end of the study. Method of measurement: scale. Waist. Timepoint: The beginning and end of the study. Method of measurement: tape measure. Food intake. Timepoint: The beginning and end of the study. Method of measurement: 24-hour feed reminder. Physical activity. Timepoint: The beginning and end of the study. Method of measurement: IPAQ questionnaire. Yazd University of Medical Sciences Approved 2024-06-10 Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences School of public health, Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd., Alam Square, Yazd Yazd Yazd Iran (Islamic Republic of)