RecruitingNot ApplicableNCT06689566

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


Sponsor

National Taiwan University Hospital

Enrollment

73 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria11

  • 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

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Interventions

DIETARY_SUPPLEMENTgenistein

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.


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

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NCT06689566


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