Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients

NCT06689566 | Recruiting

• 1 other identifier: 202404082RIND
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if genistein works to provide a beneficial effect to show lipid lowering effect and anti-inflammatory effects and slow the progression of atherosclerosis in post-myocardial infarction adults. It will also learn about the safety of genistein. The main questions it aims to answer are: Does genistein lower triglyceride in participants? What medical problems do participants have when taking genistein? Researchers will compare the baseline, under treatment and washout period triglyceride, hsCRP to see if genistein works to decrease inflammation. Participants will: Take genistein every day for 3 months with a fixed dose manner. Afterwards, there will be 3 months washout period. Visit the clinic once every month for checkups and tests. Keep a diary of their symptoms.

Conditions

Myocardial Infarction (MI)

Keywords

inflammation

Outcome Measures

Primary Outcomes (1)

• Change of triglyceride

  Reduction of triglyceride level from baseline at 3 months.

  at 3 months

Secondary Outcomes (3)

• Laboratory and functional assessment

  at 1,3,6 months

• Echocardiographic assessment of ventricular function

  at 1,3,6 months

• Functional assessment

  at 1,3,6 months

Other Outcomes (1)

• Safety outcome

  At every follow-up through study completion, with an estimated average of 1 year

Study Arms (1)

genistein group

EXPERIMENTAL

Dietary Supplement: genistein

Interventions

genistein DIETARY_SUPPLEMENT

the patients will receive genistein 250mg BID orally for complete 3 months. Afterwards, there will be 3 months washout period. Patients would then be followed for outcome measurement.

genistein group

Eligibility Criteria

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

You may qualify if:

• Written informed consent.
• Age ≥ 18 years.
• History of spontaneous myocardial infarction at least 28 days before recruitment.
• hsCRP ≥ 0.1 mg/dL
• BMI ≥ 27

You may not qualify if:

• Pregnant or nursing (lactating) women
• Women of child-bearing potential
• Planned coronary revascularization (PCI or CABG)
• Major non-cardiac surgical or endoscopic procedure within past 6 months
• Symptomatic patients with Class IV heart failure (HF) (New York Heart Association \[NYHA\].
• Uncontrolled hypertension
• Uncontrolled diabetes
• History or evidence of active tuberculosis (TB) infection
• Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy
• BMI \> 40 kg/m2
• Active cancer under treatment

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Inflammation

Interventions

Genistein

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Cho-Kai Wu

CONTACT

886-972652310; wuchokai@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 14, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)