The effectiveness of high-protein meal replacements and digital coaching in fatty liver disease

Not Applicable

• Conditions: onalcoholic steatohepatitis; Digestive System; Other specified inflammatory liver diseases

• Registration Number: ISRCTN16782046
• Lead Sponsor: Bionutrion

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-28
• Last Update Posted: 7 August 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified