This clinical trial aims to learn whether daidzein can improve liver tissue changes in adults with metabolic dysfunction-associated steatotic liver disease, also called MASLD. MASLD is a liver condition linked to extra fat in the liver and metabolic problems such as obesity, diabetes, abnormal blood lipids, or high blood pressure.
Daidzein is a natural compound found in soy. Earlier laboratory studies suggest that daidzein may help protect the liver. This study will test whether taking daidzein for a short time before surgery can improve liver tissue findings in people with MASLD.
The main questions this study aims to answer are:
Does short-term daidzein treatment improve liver tissue injury in people with MASLD? Is daidzein safe and well tolerated before surgery? Are changes in blood or urine equol levels related to the effects of daidzein? Equol is a substance made by gut bacteria after some people take daidzein.
Researchers will compare people who take daidzein before surgery with people who receive standard care without daidzein.
Participants will:
Be adults with MASLD who are scheduled for elective gallbladder surgery or another benign biliary surgery.
Be randomly assigned to take daidzein or to receive standard care without daidzein.
Take daidzein by mouth for 28 days before surgery if assigned to the daidzein group.
Avoid soy foods during the study period. Provide blood and urine samples. Have a small liver tissue sample collected during surgery. Be followed for safety and recovery after surgery.
The liver tissue sample will be used to check liver fat, inflammation, and liver cell injury. Researchers will also study markers related to liver injury, immune activity, and how the body responds to daidzein.
Adults aged 18 to 70 years.
Male or female participants.
Scheduled to undergo elective laparoscopic cholecystectomy or other benign biliary surgery for benign biliary disease.
Diagnosis of metabolic dysfunction-associated steatotic liver disease based on hepatic steatosis shown by liver biopsy or imaging, including controlled attenuation parameter, ultrasound, or magnetic resonance imaging, together with at least one cardiometabolic risk factor.
Viral hepatitis, autoimmune liver disease, drug-induced liver injury, Wilson disease, or other clearly defined chronic liver diseases.
Significant alcohol consumption, defined as more than 140 g per week for women or more than 210 g per week for men.
Liver cirrhosis, decompensated liver disease, or hepatobiliary malignancy.
Use of antibiotics, probiotics, soy isoflavone-containing products, or hormone-like dietary supplements within 4 weeks before enrollment.
Parallel
Daidzein
DrugDaidzein will be administered orally as capsules. Participants assigned to the daidzein group will take 50 mg per dose, three times daily, for a total daily dose of 150 mg. Treatment will continue for 28 consecutive days before surgery and until the day before surgery. Daidzein will be given in addition to standard perioperative care.
NAFLD Activity Score in Intraoperative Liver Tissue
The NAFLD Activity Score will be assessed using liver tissue collected during surgery. The score includes steatosis, lobular inflammation, and hepatocellular ballooning. The total score ranges from 0 to 8, with higher scores indicating greater histological activity of MASLD-related liver injury.
Steatosis Grade in Intraoperative Liver Tissue
Hepatic steatosis will be graded using intraoperative liver tissue according to the steatosis component of the NAFLD Activity Score. The score ranges from 0 to 3, with higher scores indicating more severe hepatic steatosis.
Lobular Inflammation Score in Intraoperative Liver Tissue
Lobular inflammation will be assessed using intraoperative liver tissue according to the lobular inflammation component of the NAFLD Activity Score. The score ranges from 0 to 3, with higher scores indicating more severe lobular inflammation.
Hepatocellular Ballooning Score in Intraoperative Liver Tissue
Hepatocellular ballooning will be assessed using intraoperative liver tissue according to the ballooning component of the NAFLD Activity Score. The score ranges from 0 to 2, with higher scores indicating more severe hepatocellular ballooning.
Ferroptosis-related Marker Expression in Intraoperative Liver Tissue
Ferroptosis-related markers, including GPX4 and ACSL4, will be assessed in liver tissue collected during surgery using immunohistochemistry, immunofluorescence, or other predefined protein detection methods. Quantitative or semi-quantitative expression levels will be compared between study groups.
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