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The Clinical Study on Isoflavone Genistein in Restructuring the Gut Microbiota of Hyperlipidemia Patients

NCT06895954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-03-26

No results posted yet for this study

Summary

: In preliminary animal experiments, we found that the soybean isoflavone compound Genistein could reduce serum TMAO levels in high-fat diet (HFD) mice, and this effect was dependent on the gut microbiota. Furthermore, we discovered that Genistein's regulatory effect on the gut microbiota in high-fat diet mice relies on the host colonic PKI-Nos2 pathway. Genistein is an isoflavone compound extracted from soybeans and is the most effective functional ingredient in soybean isoflavone products. It has multiple physiological functions, and several randomized controlled trials (RCTs) have shown that the intake of Genistein can effectively alleviate hyperlipidemia, obesity, metabolic syndrome, and cardiovascular diseases, suggesting its safety and efficacy as a clinical health supplement. Therefore, we aim to conduct clinical trials to further demonstrate that Genistein also influences the gut microbiota in hyperlipidemia patients, thereby reducing serum TMAO levels.

Conditions

Interventions

DIETARY_SUPPLEMENT

Genistein

Hyperlipidemia patients take a 125mg Genistein capsule daily, once a day.

Sponsors & Collaborators

  • Shenzhen Hospital of Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-13
Primary Completion
2025-02-20
Completion
2025-02-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06895954 on ClinicalTrials.gov