Metabolic dysfunction–associated steatotic liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults (male and female) in the age range of 18-65 years Have a body mass index of 18.5 to 25 Diagnosis of MASLD based on fibroscan by a gastroenterologist and in the range (7.3-17.6 kPa for fibrosis and greater than 238 dB/m for steatosis)
Exclusion criteria
Exclusion criteria: Alcohol consumption Pregnant or lactating females Having other liver diseases (including hepatitis B and C), biliary diseases, autoimmune diseases, cancer, kidney diseases, thyroid diseases, and diabetes Use of blood sugar-lowering drugs and insulin Use of medications that affect liver fat, corticosteroids, antibiotics, hepatotoxic medications, and levothyroxine Weight loss in the last 3 months Withdrawal from study follow-up Weight loss more than 10% during the study Pregnancy during study The occurrence of any severe gastrointestinal complications related to the intervention (headache, diarrhea, vomiting, abdominal pain)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in liver steatosis. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Fibroscan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver fibrosis. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study ( after 12 weeks of intervention). Method of measurement: Fibroscan.;Fasting blood sugar. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Glucose oxidase.;Serum insulin. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Elisa kit.;HOMA-IR. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Formula: HOMA-IR = (fasting insulin (µU/L) × fasting glucose (mmol/L))/22.5.;QUICKI. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Formula: QUICKI= 1 / (log (fasting insulin µU/mL) + log (fasting glucose mg/dL)).;Alanine transaminase (ALT). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Colorimetric determination.;Aspartate transaminase (AST). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Colorimetric determination.;Gamma-glutamyl transferase (GGT). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Colorimetric determination.;Weight. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (after 12 weeks of intervention). Method of measurement: Digital scale.;Waist circumference. Timepoint: At the beginning | — |
Countries
Iran (Islamic Republic of)
Contacts
Tehran University of Medical Sciences