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

This study has been completed.
Information provided by:
Imperial College London Identifier:
First received: February 6, 2006
Last updated: October 21, 2015
Last verified: February 2006
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).

Condition Intervention Phase
Coronary Artery Disease
Drug: Genistein
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease

Resource links provided by NLM:

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Coronary artery diameter [ Time Frame: On the day of angiography (day 3-4 after Supro/placebo started). No further follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coronary blood flow [ Time Frame: On the day of angiography (day 3-4 after Supro/placebo started). No further follow-up. ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: October 1999
Estimated Study Completion Date: April 2003
Arms Assigned Interventions
Experimental: Genistein
Supro drink once daily for 3 days
Drug: Genistein
Drink taken once daily
Other Name: Supro
Placebo Comparator: Placebo
Drink identical to Supro but containing no genistein, once daily for 3 days
Drug: Placebo
Drink taken once daily


Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00287690

United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Principal Investigator: Peter Collins, MD, FRCP Imperial College London
  More Information

No publications provided Identifier: NCT00287690     History of Changes
Other Study ID Numbers: 98-170
Study First Received: February 6, 2006
Last Updated: October 21, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
blood flow
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Anticarcinogenic Agents
Antineoplastic Agents
Enzyme Inhibitors
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 27, 2015