The effect of time-restricted feeding (TRF) combined with a Lacto-Ovo-Vegetarian (LOV) diet on controlling of non-alcoholic fatty liver disease

Phase 3

Recruiting

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

• Registration Number: IRCT20230821059213N1
• Lead Sponsor: Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Age over 18 years
Body mass index higher than 24.9 (BMI=25)
Having evidence of steatohepatitis and non-alcoholic fatty liver based on the confirmation of the attending physician and the patient's laboratory and ultrasound results
Not having a history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men
Willingness to participate in the study and ability to complete the study process

Exclusion Criteria

Having other chronic and acute liver diseases and disorders (hepatitis B, C, etc.), biliary disease, kidney diseases, endocrine disorders, confirmed autoimmune diseases, cancer and hereditary disorders affecting the liver (iron and copper storage disease)
Having uncontrolled cardiovascular diseases, chronic inflammatory disease, diabetes and celiac disease
Alcoholism or drug abuse
Pregnancy or Lactation in women
Consumption of hepatotoxic drugs such as phenytoin, amoxifen and lithium
Consumption of fiber, omega-3 and antioxidant supplements during the last 3 months
Consumption of weight loss drugs or supplements
Following special weight loss diets during the last 3 months
Losing more than 10% of body weight during the last 6 months
Failure to accept study conditions

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Scale.;Fibrosis index (FIB-4). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation.