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| Name | Class |
|---|---|
| Biotechnology and Biological Sciences Research Council | OTHER |
| Rothamsted Research | UNKNOWN |
| PepsiCo Global R&D | INDUSTRY |
| University of Roehampton |
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In this proposed human trial, the investigators aim to establish whether consumption of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h post-intake) in markers of cardiovascular disease risk relative to an energy matched control intervention in healthy men with high-normal to mildly elevated blood pressure.
A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole grains contain a wide range dietary components including potentially vasoactive phenolic acids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oat intervention | Active Comparator | 67.7g oatflake and 22.5g oatbran concentrate - single intake (mixed with water) |
|
| Control | Placebo Comparator | 39.4g cream of rice, 6.1g sunflower oil, 29.5g skimmed milk, 5.6g pectin powder, 6.5g cellulose and mixed with water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oat | Other | The study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilatation | Technique to assess the flexibility of the endothelium in larger peripheral blood vessels | 1 hour, 6 hours and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Laser Doppler Iontophoresis | Acute postprandial timecourse from Baseline to 2 hours, 24hours, AUC - area under the blood flow and time curve Ach-iAUC-endothelium dependent incremental area under the curve SNP-iAUC-endothelium independent incremental area under the curve Ach-AUC- endothelium dependent area under the curve | Baseline(BL), 2hours and 24hours |
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Inclusion Criteria:
Exclusion Criteria:
Males with above average blood pressure
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy P Spencer, Professor | University of Reading | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugh Sinclair Unit of Human Nutrition | Reading | Berkshire | RG6 6AP | United Kingdom | ||
| Hugh Sinclair Unit of Human Nutrition |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oat Then Control | The first intervention is oat, the second intervention is control |
| FG001 | Control Then Oat | The first intervention is control, the second intervention is oat |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| ||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participant | Crossover study - All participant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Flow Mediated Dilatation | Technique to assess the flexibility of the endothelium in larger peripheral blood vessels | Excluded data from 2 volunteers as their results were out of the normal range | Posted | Mean | Standard Error | metre | 1 hour, 6 hours and 24 hours |
|
2 months
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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 | Oat Intervention | Participants received oat intervention | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faint | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Jeremy Spencer | University of Reading | +44(0) 1183788724 | j.p.e.spencer@reading.ac.uk |
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| ID | Term |
|---|---|
| D009953 | Ornithine-Oxo-Acid Transaminase |
| ID | Term |
|---|---|
| D000637 | Transaminases |
| D019884 | Nitrogenous Group Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
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| OTHER |
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| Control | Other | 60g cream of rice |
|
| Phenolic Acids Metabolites - Ferulic Acid | Concentration of phenolic acid metabolites in plasma and urine as Assessed by liquid chromatography/mass spectrometry magnitude of increase from Baseline to 24h | Baseline, 1hour, 2 hours and 24hours |
| Plasma Nitric Oxide Analysis | Concentration of nitric oxide in nmol | Acute postprandial timecourse from Baseline, 1hour to 24hours. |
| NADPH Oxidase Activity in Neutrophil Blood Cells | NADPH oxidase activity will be calculated as the difference between values obtained in PMA The fluorescence intensity was measured by C6 Flow Cytometer | Baseline, 2 hours and 24 hours |
| Plasma Glucose | Glucose concentration in mmol/L | Acute postprandial timecourse from Baseline, 1hour to 24hours. |
| Plasma Insulin | Insulin concentration in pmol/L | Acute postprandial timecourse from Baseline, 1hour to 24hours. |
| Renin Activity | Renin activity in ng/(mL*hour) | Acute postprandial timecourse from Baseline, 1hour to 24hours. |
| Reading |
| RG66AP |
| United Kingdom |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
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| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Laser Doppler Iontophoresis | Acute postprandial timecourse from Baseline to 2 hours, 24hours, AUC - area under the blood flow and time curve Ach-iAUC-endothelium dependent incremental area under the curve SNP-iAUC-endothelium independent incremental area under the curve Ach-AUC- endothelium dependent area under the curve | Excluded data from 2 volunteers as their results were out of the normal range | Posted | Mean | Standard Error | PU per hour | Baseline(BL), 2hours and 24hours |
|
|
|
|
| Secondary | Phenolic Acids Metabolites - Ferulic Acid | Concentration of phenolic acid metabolites in plasma and urine as Assessed by liquid chromatography/mass spectrometry magnitude of increase from Baseline to 24h | Excluded data from 2 volunteers as their results were out of the normal range | Posted | Mean | Standard Deviation | nanomolars | Baseline, 1hour, 2 hours and 24hours |
|
|
|
|
| Secondary | Plasma Nitric Oxide Analysis | Concentration of nitric oxide in nmol | No data collected | Posted | Acute postprandial timecourse from Baseline, 1hour to 24hours. |
|
|
| Secondary | NADPH Oxidase Activity in Neutrophil Blood Cells | NADPH oxidase activity will be calculated as the difference between values obtained in PMA The fluorescence intensity was measured by C6 Flow Cytometer | Excluded data from 2 volunteers as their results were out of the normal range | Posted | Mean | Standard Error | fluorescence intensity | Baseline, 2 hours and 24 hours |
|
|
|
|
| Secondary | Plasma Glucose | Glucose concentration in mmol/L | Data not collected | Posted | Acute postprandial timecourse from Baseline, 1hour to 24hours. |
|
|
| Secondary | Plasma Insulin | Insulin concentration in pmol/L | Data not collected | Posted | Acute postprandial timecourse from Baseline, 1hour to 24hours. |
|
|
| Secondary | Renin Activity | Renin activity in ng/(mL*hour) | Data not collected | Posted | Acute postprandial timecourse from Baseline, 1hour to 24hours. |
|
|
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Control | Participants received control intervention | 0 | 18 | 0 | 18 | 0 | 18 |
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| D045762 |
| Enzymes and Coenzymes |
| Ach-i AUC, 24h |
|
| SNP-iAUC BL |
|
| SNP-iAUC 2h |
|
| SNP-iAUC,24h |
|
| Ach-AUC, BL |
|
| Ach-AUC, 2h |
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| Ach-AUC, 24h |
|
| 0.007 |
| Superiority |
| Ach - AUC | Mixed Models Analysis | 0.02 | Superiority |
| 2h |
|
| 24h |
|
| 24h |
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