Myocardial Infarction (MI)NCT06689566
Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients
A study testing genistein in people with Myocardial Infarction (MI), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction (MI)
- What is being tested?
- genistein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Age ≥ 18 years.
- History of spontaneous myocardial infarction at least 28 days before recruitment.
- hsCRP ≥ 0.1 mg/dL
- BMI ≥ 27
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
CHO-KAI WU, MD, PhD, 0972652310, wuchokai@gmail.com
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Myocardial Infarction (MI)
- Being tested
- genistein
- Keywords
- inflammation
- Medical subject headings
- Myocardial Infarction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genisteinDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| genistein group | Experimental | Not described Receives: Dietary Supplement: genistein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of triglyceride
Reduction of triglyceride level from baseline at 3 months.
Measured: at 3 months
Secondary outcomes (3)
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
Measured: at 1,3,6 months
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)
Measured: at 1,3,6 months
Functional assessment
6-minute walking test (m)
Measured: at 1,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689566
- Sponsor's protocol ID
- 202404082RIND
- Status last verified
- Aug 2025
- First submitted
- 4 Nov 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT06689566
- Acronym / sponsor ID
- 202404082RIND
- Conditions
- Myocardial Infarction (MI)
- Keywords
- inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| genistein group | Experimental | Dietary Supplement: genistein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent.
- Age ≥ 18 years.
- History of spontaneous myocardial infarction at least 28 days before recruitment.
- hsCRP ≥ 0.1 mg/dL
- BMI ≥ 27
Key exclusion criteria (11 listed)
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genisteinthe 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. | Dietary supplement | genistein group |
Primary outcome
Change of triglyceride
Time frame: at 3 months
Reduction of triglyceride level from baseline at 3 months.
3 secondary outcomes
Laboratory and functional assessment
Time frame: at 1,3,6 months
Echocardiographic assessment of ventricular function
Time frame: at 1,3,6 months
Functional assessment
Time frame: at 1,3,6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genistein in people with Myocardial Infarction (MI), run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cho-Kai Wu (886-972652310, wuchokai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of triglyceride (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.