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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genistein | Experimental | Supro drink once daily for 3 days |
|
| Placebo | Placebo Comparator | Drink identical to Supro but containing no genistein, once daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genistein | Drug | Drink taken once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Coronary Artery Diameter | Coronary angiograms were acquired digitally using a real-time digital image acquisition system (Siemens AG, Berlin and Munich, Germany) and analysed off-line using quantitative coronary angiography (MEDIS, Leiden, The Netherlands). Basal luminal diameter of the entire coronary artery (mean luminal diameter) was measured for all subjects. Mean luminal diameter and luminal diameter approximately 4 mm distal to the tip of the Doppler wire were measured. The latter measurements were used to quantify volume flow as described previously. Data below are mean coronary artery diameter response following infusion of acetylcholine (ACh 10-5 M). | Day 3-4 after Supro/placebo started. |
| Coronary Blood Flow | Measurement of diameter 4mm distal to the Doppler wire tip (measured using quantitative coronary angiography) and blood flow velocity, measured using intracoronary Doppler), were made at baseline and at peak velocity change. A quantitative estimate of coronary blood flow was calculated from the Doppler flow velocity and quantitative angiographic data using the following equation: Q = 3.14(D2/4)(APV/2)(0.6) where Q is flow (ml/min), D is vessel diameter (mm) and APV is average peak velocity (cm/s). Data below are measurements taken at peak blood flow response following an infusion of acetylcholine (10-5M). | Day 3-4 after Supro/placebo started. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Genistein Concentrations | Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK). | Day 3 after Supro/placebo started. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Collins, MD, FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton & Harefield NHS Trust | London | SW3 6NP | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Genistein | Supro drink once daily for 3 days prior to coronary angiography Genistein: Drink taken once daily |
| FG001 | Placebo | Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography. Placebo: Drink taken once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Genistein | Supro drink once daily for 3 days Genistein: Drink taken once daily |
| BG001 | Placebo | Drink identical to Supro but containing no genistein, once daily for 3 days Placebo: Drink taken once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Coronary Artery Diameter | Coronary angiograms were acquired digitally using a real-time digital image acquisition system (Siemens AG, Berlin and Munich, Germany) and analysed off-line using quantitative coronary angiography (MEDIS, Leiden, The Netherlands). Basal luminal diameter of the entire coronary artery (mean luminal diameter) was measured for all subjects. Mean luminal diameter and luminal diameter approximately 4 mm distal to the tip of the Doppler wire were measured. The latter measurements were used to quantify volume flow as described previously. Data below are mean coronary artery diameter response following infusion of acetylcholine (ACh 10-5 M). | Posted | Mean | Standard Deviation | mm | Day 3-4 after Supro/placebo started. |
|
From enrollment to study end, approximately 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genistein | Supro drink once daily for 3 days prior to coronary angiography Genistein: Drink taken once daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Carolyn Webb | Imperial College London | +44 3301288121 | c.webb@imperial.ac.uk |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Placebo | Drug | Drink taken once daily |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography. Placebo: Drink taken once daily |
|
|
| Primary | Coronary Blood Flow | Measurement of diameter 4mm distal to the Doppler wire tip (measured using quantitative coronary angiography) and blood flow velocity, measured using intracoronary Doppler), were made at baseline and at peak velocity change. A quantitative estimate of coronary blood flow was calculated from the Doppler flow velocity and quantitative angiographic data using the following equation: Q = 3.14(D2/4)(APV/2)(0.6) where Q is flow (ml/min), D is vessel diameter (mm) and APV is average peak velocity (cm/s). Data below are measurements taken at peak blood flow response following an infusion of acetylcholine (10-5M). | Posted | Mean | Standard Deviation | ml/min | Day 3-4 after Supro/placebo started. |
|
|
|
| Secondary | Serum Genistein Concentrations | Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK). | Posted | Median | 95% Confidence Interval | ng/ml | Day 3 after Supro/placebo started. |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Placebo | Drink identical to Supro but containing no genistein, once daily for 3 days prior to coronary angiography. Placebo: Drink taken once daily | 0 | 12 | 0 | 12 | 0 | 12 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |