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

Comparison of the effect of Oral Synbiotics and L-Carnitine on Lipid Profiles and Liver Functional Tests in Non-Alcoholic Fatty Liver Disease Patients: Double Blinded Randomized Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230212057393N1

Enrollment

105

Registered

2023-04-15

Start date

2023-04-09

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group 1: Thirty-five Patients are in the L-Carnitine Supplements Intervention Group. Patients will receive L-carnitine 500 mg twice daily for three months. Intervention 2:

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahime Naderi Behdani

Mazandaran University of Medical Sciences

fahime.naderi90@gmail.com+98 915 769 6456

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026