Genistein to lower lipids and inflammation after a heart attack

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

This trial will test whether taking genistein every day for three months lowers triglycerides and inflammation in adults who have had a heart attack.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 73 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Drugs / interventions: canakinumab
• Locations: 1 site (Taipei, Taiwan)
• Trial ID: NCT06689566 on ClinicalTrials.gov

What this trial studies

This is a phase 2, single-center, dose-escalation interventional trial comparing genistein to placebo in stable adults after myocardial infarction who have elevated hsCRP. Participants will take a fixed daily dose of genistein for three months followed by a three-month washout, with monthly clinic visits for tests and safety checks. Key measurements include triglycerides and high-sensitivity C-reactive protein (hsCRP) at baseline, during treatment, and after washout, plus monitoring for adverse events and screening for cancer and tuberculosis. Eligible patients are adults at least 28 days post-MI, on stable therapy, with hsCRP ≥ 0.1 mg/dL and BMI ≥ 27.

Who should consider this trial

Good fit: Adults (≥18) who had a spontaneous myocardial infarction at least 28 days earlier, have hsCRP ≥ 0.1 mg/dL, a BMI ≥ 27, and are on stable long-term medical therapy are the intended candidates.

Not a fit: Patients who are pregnant or lactating, of child-bearing potential, have uncontrolled hypertension or diabetes, recent major surgery, active cancer or tuberculosis, planned coronary revascularization, class IV heart failure, or BMI > 40 are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, genistein could lower triglycerides and systemic inflammation, potentially slowing atherosclerosis progression and reducing recurrent cardiovascular events.

How similar studies have performed: Anti-inflammatory approaches such as canakinumab and colchicine have reduced recurrent cardiovascular events in other trials, but genistein's lipid-lowering and anti-inflammatory effects have so far been reported mainly in preclinical studies and remain unproven in humans.

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Where this trial is running

Taipei, Taiwan

• National Taiwan University Hospital — Taipei, Taiwan, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Cho-Kai Wu

Conditions: Myocardial Infarction, inflammation