Comparison of the effect of Oral Synbiotics and L-Carnitine on Lipid Profiles and Liver Functional Tests

Phase 3

Recruiting

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

Registration Number: IRCT20230212057393N1

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 105

Inclusion Criteria

All patients over 18 years old with non-alcoholic fatty liver disease without autoimmune, viral, and metabolic causes

Exclusion Criteria

Consumption of any probiotic, prebiotic, or synbiotic products in the last three months
Pregnant and lactating women
Positive test for hepatitis A, B, C, or HIV
Autoimmune hepatitis
Hypothyroidism
Wilson disease
Hemochromatosis
Gastrointestinal disorders
Alcohol consumption
The use of antibiotics in the last three months
Consumption of drugs affecting liver function
Patients who cannot complete the study period
Consumption of any supplement or medicinal product containing L-Carnitine in the last 3 months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sonography evaluation. Timepoint: At the Baseline and Three months after Entering The Trial. Method of measurement: Sonography.;Lipid Profiles. Timepoint: At the Baseline and Three months after Entering The Trial. Method of measurement: Blood test.;Liver Functional Tests. Timepoint: At the Baseline and Three months after Entering The Trial. Method of measurement: blood test.;AST/Platelets Ratio (APRI). Timepoint: At the Baseline and Three months after Entering The Trial. Method of measurement: Blood test.

Secondary Outcome Measures

Name	Time	Method
HOMA-IR Index. Timepoint: At the Baseline and Three months after Entering The Trial. Method of measurement: HOMA-IR.;Body Mass Index. Timepoint: At the Baseline and Three months after Entering The Trial. Method of measurement: BMI.;Systolic and Diastolic Blood Pressure. Timepoint: At the Baseline and Three months after Entering The Trial. Method of measurement: Mercury Sphygmomanometer.;Measure psychological disorder. Timepoint: At the Baseline and Three months after Entering The Trial. Method of measurement: The General Health Questionnaire – 28.;Appetite assessment. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone.;Evaluating the stool condition of patients. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone.