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

NCT07623044 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-06-03

No results posted yet for this study

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

Interventions

DRUG

Daidzein

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.

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    lead OTHER

Principal Investigators

  • Feng Shen, MD, PhD · Clinical Research Institute, Eastern Hepatobiliary Surgery Hospital and National Centre for Liver Cancer, Naval Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-21
Primary Completion
2026-07-10
Completion
2026-08-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623044 on ClinicalTrials.gov