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NCT07623044
Effects of Short-term Perioperative Daidzein Intervention on Liver Histopathology in Patients With MASLD
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 44
Sponsor: Eastern Hepatobiliary Surgery Hospital
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
* Expected preoperative window of at least 28 days before surgery.
* Able and willing to provide written informed consent.
* Willing to provide blood samples, urine samples, and intraoperative liver tissue samples.
* Able and willing to avoid soy-containing foods during the study period, including soybeans, edamame, black soybeans, soy milk, tofu, dried tofu, tofu skin, yuba, tofu pudding, natto, miso, fermented soybeans, tempeh, and other traditional or fermented soy products.
Exclusion Criteria:
* 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.
* Treatment within 3 months before enrollment that may substantially affect body weight or the severity of fatty liver disease.
* Known allergy to soy products, daidzein, or isoflavones.
* Pregnancy or breastfeeding.
* Any condition that, in the opinion of the investigator, makes the participant unsuitable for this study.
Source: ClinicalTrials.gov (NCT07623044). StuddyBuddy aggregates publicly available trial information.
