Phase 3 N=71 Randomized Quadruple-blind Treatment

Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT00287690 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Coronary Artery Diameter — 3.1; 2.7 mm

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Genistein (Drug); Placebo (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Aug 2003

Outcome Measures

Outcome	Result	p-value
PRIMARY Coronary Artery Diameter	3.1; 2.7	—
PRIMARY Coronary Blood Flow	77; 68	—
SECONDARY Serum Genistein Concentrations	340; 3.9	—

Summary

The aim of this study is to investigate the effect of genistein administration on coronary arteries in humans. We will measure the size of a coronary artery and the speed and amount of blood flow in response after subjects have ingested Supro® drinks (a soy protein drink containing genistein).

Eligibility Criteria

Inclusion Criteria

Aged 30-75 years
Patients requiring diagnostic coronary angiography
Presence of coronary artery disease on angiogram but with at least one non-obstructed (lesions 40 IU/L)
Willing to give informed, written consent

Exclusion Criteria

Age 75 years
Allergy to radiographic contrast media
Sino-atrial disease or significant bradycardia
Concomitant medication with persantin (dipyridamole) or theophyllines
Asthma
Hypertension
Left ventricular hypertrophy or dysfunction (clinical/ECG/echo/CXR)
Female patients with FSH<40 IU/L (postmenopausal)
Female patients currently taking hormone therapy, or who have taken hormone therapy in previous 6 months
Unwilling to give written informed consent
Participation in another study within previous 60 days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00287690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.