Investigating the effect of royal jelly supplement in non-alcoholic fatty liver disease

Phase 2

Recruiting

Conditions: on-alcoholic fatty liver.
Fatty (change of) liver, not elsewhere classified
K76.0

Registration Number: IRCT20110510006431N7

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 46

Inclusion Criteria

Age 18 to 65 years
diagnosis of NAFLD using ultrasound imaging
Body mass index (BMI) 25 and above
fasting blood sugar less than 126
no history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men

Exclusion Criteria

Smoking
history of liver, cardiovascular, pulmonary, kidney disease, celiac disease
use of lipid-lowering drugs
regular exercise six months before the study
basic diet changes
weight change of more than 5% in 3 months before screening
History of gastric surgeries for weight loss
patients using dietary supplements containing n-3 or n-6 fatty acids, vitamin D, E and other antioxidants or fiber supplements in the 12 weeks before the start of the study
history of thyroid problems
non-compliance Principles of the study protocol

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TG?Total Cholestrol ? LDL ? HDL C ?ALT? AST ?GGT ? TNF a ? CRP. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: 5 cc of blood is taken to measure the concentration of liver enzymes, lipid profile, inflammatory factors and it is measured by enzymatic methods and using a kit.

Secondary Outcome Measures

Name	Time	Method
Weight, body mass index (BMI), waist circumference, hip circumference, ratio of waist circumference to hip circumference, serum glucose, serum insulin, insulin resistance (HOMA-IR), quantitative insulin sensitivity index (QUICKI). Timepoint: At the beginning of the study and after 8 weeks after the intervention. Method of measurement: Taking blood samples using laboratory methods, the weight of each patient is measured with a scale with an accuracy of 100 grams, and the height of each patient without shoes is measured with a height meter with an accuracy of 0.5 cm. The body mass index (BMI) of the patients is calculated, the patient's waist and hips are measured using a tape measure with an accuracy of 0.5 cm, and finally, the body fat percentage of the patients is measured with an in-body device.