Effects of Short-term Perioperative Daidzein Intervention on Liver Histopathology in Patients With MASLD

NCT07623044 | Not Yet Recruiting Phase 2

• 2 other identifiers: EHBHKY2026-H009-P001SHDC2023CRW002
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Metabolic dysfunction-associated steatotic liver disease; Daidzein; Ferroptosis; Randomized controlled trial; Soy isoflavone

Outcome Measures

Primary Outcomes (1)

• 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.

  At the time of surgery

Secondary Outcomes (11)

• Steatosis Grade in Intraoperative Liver Tissue

  At the time of surgery

• Lobular Inflammation Score in Intraoperative Liver Tissue

  At the time of surgery

• Hepatocellular Ballooning Score in Intraoperative Liver Tissue

  At the time of surgery

• Ferroptosis-related Marker Expression in Intraoperative Liver Tissue

  At the time of surgery

• CD8-positive T-cell Infiltration in Intraoperative Liver Tissue

  At the time of surgery

Study Arms (2)

Daidzein Group

EXPERIMENTAL

Participants assigned to this arm will receive oral daidzein capsules before surgery in addition to standard perioperative care. Daidzein will be administered for 28 consecutive days before the planned elective laparoscopic cholecystectomy or other benign biliary surgery. Participants will undergo surgery according to routine clinical practice, and a small liver tissue sample will be collected intraoperatively for histological and biomarker assessment.

Drug: Daidzein

Control Group

NO INTERVENTION

Participants assigned to this arm will receive standard perioperative care without daidzein intervention. They will undergo the planned elective laparoscopic cholecystectomy or other benign biliary surgery according to routine clinical practice. A small liver tissue sample will be collected intraoperatively for histological and biomarker assessment. 中文对应

Interventions

Daidzein DRUG

Daidzein 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.

Daidzein Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

MeSH Terms

Interventions

daidzein

Study Officials

• Feng Shen, MD, PhD

  Clinical Research Institute, Eastern Hepatobiliary Surgery Hospital and National Centre for Liver Cancer, Naval Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Shen, MD、PhD

CONTACT

+86-21-81875005; shenfengdfgd@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, open-label, randomized, parallel-group controlled study. Eligible participants with metabolic dysfunction-associated steatotic liver disease who are scheduled for elective laparoscopic cholecystectomy or other benign biliary surgery will be assigned in a 1:1 ratio to receive short-term preoperative daidzein intervention or standard perioperative care without daidzein. Both groups will undergo the planned surgery according to routine clinical practice. Liver tissue collected during surgery will be used for histological and biomarker assessment.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 3, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available beginning 6 months after publication of the main study results and will be available for 3 years.
• Access Criteria: Data will be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the principal investigator and the study team. Data sharing will require approval of the proposed analysis, a signed data use agreement, and compliance with applicable ethical and privacy requirements. Data may be used for academic, non-commercial research related to MASLD, daidzein, liver histopathology, metabolic biomarkers, or related translational analyses.