Short-Term Daidzein Intervention in MASLD
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
研究概览
简要总结
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.
详细描述
Metabolic dysfunction-associated steatotic liver disease, or MASLD, is one of the most common chronic liver diseases. It is closely associated with obesity, type 2 diabetes, dyslipidemia, hypertension, and other cardiometabolic risk factors. MASLD is diagnosed when hepatic steatosis is present together with at least one cardiometabolic risk factor. Its disease spectrum ranges from simple steatosis to steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma. Because of its high prevalence and potential for disease progression, MASLD has become an important public health problem.
Current treatment strategies for MASLD mainly include weight reduction, dietary control, physical activity, and management of metabolic abnormalities. However, these approaches may be difficult to standardize and maintain over time, and treatment responses vary among individuals. There remains a need for safe, practical, and mechanism-based interventions that may improve liver injury and disease activity in MASLD.
MASLD is not only a metabolic liver disease but also an immunometabolic disease. Its development and progression involve hepatic lipid accumulation, oxidative stress, hepatocellular injury, ferroptosis-related biological changes, and immune-inflammatory responses. However, direct evidence from human liver tissue remains limited. In particular, it is unclear whether a short-term, mechanism-oriented intervention can induce measurable changes in liver histology, ferroptosis-related markers, and intrahepatic immune-inflammatory features in patients with MASLD.
Daidzein is an important bioactive component of soy isoflavones. It has been reported to have metabolic regulatory, antioxidant, and anti-inflammatory properties. Previous experimental studies by the investigators suggest that daidzein can improve metabolic dysfunction and reduce liver injury in MASLD models. These studies also suggest that the beneficial effects of daidzein may depend, at least in part, on gut microbiota-mediated metabolic conversion.
The investigators' preclinical work combining metagenomic and metabolomic analyses identified equol as a key gut microbiota-derived metabolite that increases after daidzein intervention. Mechanistic findings suggest that the daidzein-equol axis may improve MASLD-related liver injury by coordinating hepatocyte protection and restraint of immune-inflammatory responses. These findings provide a scientific basis for evaluating daidzein in a clinical translational setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an open-label study for participants, care providers, and investigators. Outcome assessors for liver histopathology and key biomarker analyses will be masked to treatment assignment whenever feasible. Liver tissue samples and related laboratory specimens will be coded and de-identified before assessment to reduce evaluation bias.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Shen Feng
Principal Investigator
Eastern Hepatobiliary Surgery Hospital