Nonalcoholic steatohepatitis Digestive System Other specified inflammatory liver diseases
Conditions
Interventions
1. High-protein meal replacements at dinner. The meal replacements are commercially available, consisting of 150 kcal, 21g of protein, 14g of carbohydrates, and 1g of fat. The researchers recommend me
Sponsors
Bionutrion
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 to 65 years 2. Obese with a body mass index of 25 kg/m² or higher 3. Ultrasonically observed fatty liver within 1 month of evaluation 4. Alanine transferase level between 40 and 200 IU/L 5. AST/ALT ratio <1
Exclusion criteria
Exclusion criteria: 1. Body mass index below 25 kg/m² 2. Hepatitis B/C is confirmed in the medical examination or has a history of viral hepatitis 3. Meaningful alcohol consumption (140 g per week for women and 210 g for men) 4. Drug-induced fatty liver and toxic hepatitis (statin, steroid, amiodarone, rheumatoid arthritis, tamoxifen, and those who take health supplements containing biopharmaceuticals/han drugs) (*However, it can be registered during stable doses within at least 12 weeks) 5. Those who are unable to control their diet or exercise due to severe heart, lung, and underlying diseases (heart failure, ischemic heart disease, third-degree atrioventricular block, chronic obstructive pulmonary disease) 6. A person who is unable to control his/her diet or exercise due to a serious mental illness 7. Oral hemolytic drugs or insulin treatments for diabetes (if diagnosed with diabetes but determined to be treatable through lifestyle modification without drug treatment, registration can be made at the researcher's decision) 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function tests including alanine transferase (ALT) measured using the NADH-UV method at baseline and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Height is measured on an electronic scale at baseline 2. Weight and body composition assessment using bioelectrical impedance analysis at baseline and 4 weeks 3. Waist circumference is measured with a measuring tape at the midline between the lowest rib margin and the iliac crest by the same personnel at baseline and 4 weeks 4. Blood pressure is measured with an electronic blood pressure meter at baseline and 4 weeks 5. Fasting blood glucose level measured using the hexokinase method at baseline and 4 weeks 6. Total cholesterol, high-density lipoprotein cholesterol measured using homogeneous enzymatic assays and triglycerides using a glycerol-3-phosphate oxidase peroxide method at baseline and 4 weeks 7. Glycated hemoglobin measured using a Bio-Rad Variant ll Turbo high-performance liquid chromatography analyser at baseline 8. Blood urea nitrogen measured using urease/glutamate dehydrogenase methods at baseline 9. Creatinine measured using Jaffe's kinetic method at baseline | — |
Countries
Korea, South
Outcome results
None listed