Comparison of two different types of diet on the levels of factors related to non-alcoholic fatty liver disease in children and adolescents

Comparison of the effect of a low-carbohydrate diet with restricted calories and a standard diet with restricted calories on the levels of liver enzymes, insulin resistance and body composition in obese or overweight children and adolescents with non-alcoholic fatty liver disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151128025267N8

Enrollment

Registered

2025-02-16

Start date

2024-11-21

Completion date

Unknown

Last updated

2025-07-21

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: receiving a low-carbohydrate diet with restricted calories for 12 weeks (percentage distribution of macronutrients for carbohydrates, protein and fat is equal to 50

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age 5 to 18 years Obesity or overweight NAFLD based on serum ALT levels

Exclusion criteria

Exclusion criteria: Suffering from other liver diseases Suffering from autoimmune diseases Suffering from hereditary metabolic diseases History of receiving parental nutrition History of taking steatogenic drugs alcohol consumption pregnancy

Design outcomes

Primary

Measure	Time frame
Alanine amino teransferase. Timepoint: One week before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Blood test and measurement of its values ??in serum.;Aspartate amino teransferase. Timepoint: One week before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Blood test and measurement of its values ??in serum.	—

Measure

Time frame

Alanine amino teransferase. Timepoint: One week before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Blood test and measurement of its values ??in serum.;Aspartate amino teransferase. Timepoint: One week before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Blood test and measurement of its values ??in serum.

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Secondary

Measure	Time frame
Insulin resistance by HOMA-IR index. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: First, measuring fasting glucose and insulin in the serum and then calculating by the formula (Insulin (mU/L) × Glucose (mg/dL)) / 405.;Serum insulin. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Serum glucose. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: The glucose oxidase-peroxidase coupled method (GOD-POD).;Serum triglyceride. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Total serum cholesterol. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Serum high-density lipoprotein (LDL). Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Serum low-density lipoprotein (LDL). Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Body weight. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Body analyzer.;Height. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: height gauge.;Body mass index (BMI) Z-score. Timepoint	—

Measure

Time frame

Insulin resistance by HOMA-IR index. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: First, measuring fasting glucose and insulin in the serum and then calculating by the formula (Insulin (mU/L) × Glucose (mg/dL)) / 405.;Serum insulin. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Serum glucose. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: The glucose oxidase-peroxidase coupled method (GOD-POD).;Serum triglyceride. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Total serum cholesterol. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Serum high-density lipoprotein (LDL). Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Serum low-density lipoprotein (LDL). Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Enzymatic spectrophotometer method.;Body weight. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: Body analyzer.;Height. Timepoint: before the beginning of the study and immediately after the end of the study (the intervention period is 12 weeks). Method of measurement: height gauge.;Body mass index (BMI) Z-score. Timepoint

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Mahmoudi

Tehran University of Medical Sciences

maryam.mahmoudi73@gmail.com0218895574

Outcome results

None listed

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