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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00287690
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : October 22, 2015
Information provided by:
Imperial College London

February 6, 2006
February 7, 2006
October 22, 2015
October 1999
Not Provided
Coronary artery diameter [ Time Frame: On the day of angiography (day 3-4 after Supro/placebo started). No further follow-up. ]
Coronary artery diameter
Complete list of historical versions of study NCT00287690 on ClinicalTrials.gov Archive Site
Coronary blood flow [ Time Frame: On the day of angiography (day 3-4 after Supro/placebo started). No further follow-up. ]
Coronary blood flow
Not Provided
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Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease
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).
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Genistein
    Drink taken once daily
    Other Name: Supro
  • Drug: Placebo
    Drink taken once daily
  • Experimental: Genistein
    Supro drink once daily for 3 days
    Intervention: Drug: Genistein
  • Placebo Comparator: Placebo
    Drink identical to Supro but containing no genistein, once daily for 3 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2003
Not Provided

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 <70% narrowed compared with the adjacent normal part of the vessel) atheromatous vessel (confirmed at diagnostic cardiac catheterisation)
  • Female patients must be postmenopausal (FSH>40 IU/L)
  • Willing to give informed, written consent

Exclusion Criteria:

  • Age <30 or >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
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
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Not Provided
Imperial College London
Not Provided
Principal Investigator: Peter Collins, MD, FRCP Imperial College London
Imperial College London
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP