Genistein to lower lipids and inflammation after a heart attack
Official title: Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients
Run by National Taiwan University Hospital · NCT06689566 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 73 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | canakinumab |
| Locations | 1 site (Taipei, Taiwan) |
| Status | Recruiting |
| Started | September 2025 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | August 7, 2025 |
| Trial ID | NCT06689566 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
National Taiwan University Hospital
Taipei, Taiwan, Taiwan Recruiting
Study contacts
- Study coordinator: Cho-Kai Wu
- Email: wuchokai@gmail.com
- Phone: 886-972652310
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.