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

Determining 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.

The present study will be conducted with a 2 by 2 parallel design in order to investigate compliance with the GDQS diet and artichoke supplement consumption in 4 groups and each group will include 25 people with non-alcoholic fatty liver disease for 8 weeks.

Non-alcoholic fatty liver,in Ilam city The participants are randomly divided into 4 groups GDQS diet + supplement, GDQS diet + placebo, standard diet + supplement, standard diet + placebo. The intervention and control groups will receive three artichoke capsules and three placebo capsules daily for eight weeks. Anthropometric indicators including weight, height and waist circumference, physical activity level using IPAQ questionnaire, compliance with the GDQS diet using a three-day food diary and fatty liver grade Non-alcoholic will be evaluated using sonographic findings as well as biochemical tests

People diagnosed with hepatic steatosis (grades 1 to 3) based on liver ultrasound are selected from among adults aged 18 and above referring to gastroenterology and liver clinics. Non-entry criteria include pregnancy or breastfeeding؛ hepatitis؛ coronary؛ kidney؛ lung؛ and thyroid diseases.

Individuals will be randomly assigned to one of four groups as follows. First group: GDQS diet + supplement, second group: GDQS diet + placebo, third group: standard diet + supplement, fourth group: standard diet + placebo.

sonographic findings; liver enzymes ALT and AST; anthropometric indicators of weight, waist circumference and BMI; fasting blood sugar; LDL-c; HDL-c; TG

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.

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.

primary outcome will be available at the end of study

6 months after the results are published

Academic institutions

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.

Sayyed Saeid Khayyatzadeh Assistant professor of nutrition in Shahid Sadoughi university of medical sciences Khayyatzadeh@yahoo.com 00983538209100

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