跳至主要内容
临床试验/ISRCTN16782046
ISRCTN16782046进行中(未招募)Unknown

Efficacy of high-protein meal replacements and digital coaching on nonalcoholic steatohepatitis: a stepped wedge randomized controlled trial

Bionutrion0 个研究点目标入组 60 人开始时间: 2023年7月28日最近更新:

试验速览

阶段
Unknown
状态
进行中(未招募)
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Bionutrion

相似试验