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| Name | Class |
|---|---|
| Danisco | INDUSTRY |
| Coressence LTD | UNKNOWN |
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The main purpose of this study is to determine the oral bioavailability of flavanols (polyphenolic compounds) from apple granules and an apple extract delivered in a water based beverage at two different doses. We will also investigate the effects of apple flavanols on nitric oxide production.
This study is a randomized four phase crossover trial investigating the bioavailability of apple flavanols and the effects on nitric oxide products, a surrogate marker for changes in endothelial function. Each test phase will comprise a 3 day period of intervention which will be identical in nature (except for the test product consumed) and separated by a minimum of 1 week. On days 1-3 of each test phase volunteers will consume a low flavanol diet. After consumption of the test product on the morning of day 2, blood and urine samples will be collected at regular intervals for the next 24h.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apple flavanols | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple extract delivering 70 mg epicatechin | Other | Delivered as a flavoured water based beverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma pharmacokinetic curve for total epicatechin | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Additional measures of bioavailability: Plasma Cmax, Tmax, half life and urinary excretion | 24 hours | |
| Changes in levels of nitric Oxide metabolites as a surrogate measure of endothelial function after consumption of apple flavanols | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Kroon | Quadram Institute Bioscience | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Food Research | Norwich | Norfolk | NR4 7UA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22373658 | Derived | Saha S, Hollands W, Needs PW, Ostertag LM, de Roos B, Duthie GG, Kroon PA. Human O-sulfated metabolites of (-)-epicatechin and methyl-(-)-epicatechin are poor substrates for commercial aryl-sulfatases: implications for studies concerned with quantifying epicatechin bioavailability. Pharmacol Res. 2012 Jun;65(6):592-602. doi: 10.1016/j.phrs.2012.02.005. Epub 2012 Feb 25. |
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| ID | Term |
|---|---|
| D002392 | Catechin |
| ID | Term |
|---|---|
| D002839 | Chromans |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Apple extract delivering 140 mg epicatechin | Other | Delivered as a flavoured water based beverage |
|
| Apple granules delivering 70 mg epicatechin | Other | Delivered as a puree |
|
| Water delivering no epicatechin | Other | Delivered as flavoured water |
|
| D006571 |
| Heterocyclic Compounds |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |