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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction (MI)
• Intervention / Treatment: Dietary supplement: genistein

Detailed Description

Background Current medical treatment for slowing the progression of atherosclerosis focus on lipid control and anti-platelet agent use. Systemic inflammation is associated with an increased risk of cardiovascular events, independent of the cholesterol level. Recent studies showed that anti-inflammatory therapy with canakinumab or colchicine led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. Genistein was reported to be associated with anti-inflammatory and lipid lowering effects in preclinical studies. Thus, we hypothesized that genistein could provide a beneficial effect to show lipid lowering effect and anti-inflammatory effects and slow the progression of atherosclerosis.

Method The study is a phase 2 sing-center, dose-escalation clinical trial to evaluate the benefit of genistein compared to placebo among stable post-MI patients receiving standard of care therapy who have been selected for an elevated inflammatory burden as determined by high sensitivity C-reactive protein (hsCRP) > 0.1 mg/dL

Screening will take place no earlier than 28 days after the index MI and on stable (at least 4 weeks) long term medication. Evaluations will include hsCRP and determination of cancer, tuberculosis status among other measurements and procedures and will be done at a cardiology clinic. For patients who underwent percutaneous coronary intervention (PCI) at different hospital admission than the qualifying MI; screening can be initiated no earlier than 28 days following this procedure.

Intervention Patients will be screened for suitability of genistein treatment, and the trial would be initiated after informed consent. After initiation, 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.

Follow-up Laboratory data would be checked 0, 1, 3, 6 months as well as clinics follow-up. Echocardiography and 6-minute walking test will be checked at 0, 3 months. Major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, hospitalization for heart failure, or confirmed death from cardiovascular causes will be documented. Further follow-up would be arranged according to local guidelines until 2027/12/31 then according to patient's condition and local medical guidance.

• Study Type: Interventional
• Enrollment (Estimated): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cho-Kai Wu; Phone Number: 886-972652310; Email: wuchokai@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: CHO-KAI WU, MD, PhD; Phone Number: 0972652310; Email: wuchokai@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: genistein group	Dietary supplement: genistein; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of triglyceride	Reduction of triglyceride level from baseline at 3 months.	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic assessment of ventricular function	echocardiographic feature of chamber function including left ventricular ejection fraction(%), left ventricular internal diameter in end diastole (cm), left atrium dimension (mm)	at 1,3,6 months
Functional assessment	6-minute walking test (m)	at 1,3,6 months
Laboratory and functional assessment	Lipid profile including total cholesterol(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), triglyceride(mg/dL) and hsCRP, HOMA-IR, TNF-alpha, IL-6	at 1,3,6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	Patient reported symptoms including allergic reaction	At every follow-up through study completion, with an estimated average of 1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: inflammation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Protein Kinase Inhibitors; Protective Agents; Estrogens; Phytoestrogens; Estrogens, Non-Steroidal; Anticarcinogenic Agents; Genistein
• Other Study ID Numbers: 202404082RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No