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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
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There is substantial interest in the potential role of chocolate and its primary bioactive component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of cardiovascular disease (CVD). Numerous observational studies have found the association between high cocoa intake and a reduced CVD risk and mortality, yet the impact of these mechanisms in vivo is unclear. In order to have a beneficial effect, these cocoa flavan-3-ols must be absorbed in the body in a forms, while still maintaining its advantageous characteristics. Consumption studies with ileostomists who have had their colon removed,provide information regarding the bioavailability and bioactivity of (-)-epicatechin and flavan-3-ols from cocoa, therefore the aim of this study is to determine the impact of methylaxanthines (including theobromine) on bioavailability of cocoa flavan-3-ols prior to entering the colon.
This study has a randomised double blinded crossover control design, being applied to ileostomy patients who are aged 18-65 years, N=10, 5 per group. The study is divided into two phases. During the first phase, subjects will partake in a 2-day restriction diet (No phenolic foods) and an overnight fast prior to sampling. Ileal fluid (0hr) is obtained from participants. They will then be asked to consume the cocoa flavanol beverage dissolved in 310g 1% milk. After this urine and ieal fluid is collected every 4 hours at 3 more time points and blood every hour at 8 time points. A 24 hr urine and ieal fluid sample is collected the following day. There will be a 1-week wash out period between each phase. Procedure is repeated again for phase 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocoa Flavanol beverage mix | Placebo Comparator | Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg & theobromine, 93mg) |
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| De-xanthinated Cocoa Flavanol beverage mix | Experimental | De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg & theobromine, 0.2mg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocoa Flavanol beverage mix | Dietary Supplement | Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk. |
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| Measure | Description | Time Frame |
|---|---|---|
| cocoa flavan-3-ols bio-availability | Recovery of ingested flavan-3-ols in ileal fluid | 24-hour period post-consumption |
| cocoa flavan-3-ols bio-availability | Uptake of ingested flavan-3-ols in plasma | Change over 8-hour period post-consumption |
| cocoa flavan-3-ols availability | Recovery of ingested flavan-3-ols in urine | Change over 24-hour period post-consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Simulated gut microbiota | Ileal fluid with/without simulated colonic fermentation | Change over 24-hour in vitro fermentation period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit, Ulster University | Coleraine | Co.Londonderry | BT52 1SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36621554 | Derived | Ottaviani JI, Fong RY, Borges G, Kimball J, Ensunsa JL, Medici V, Pourshahidi LK, Kane E, Ward K, Durkan R, Dobani S, Lawther R, O'Connor G, Gill CIR, Schroeter H, Crozier A. Flavan-3-ol-methylxanthine interactions: Modulation of flavan-3-ol bioavailability in volunteers with a functional colon and an ileostomy. Free Radic Biol Med. 2023 Feb 20;196:1-8. doi: 10.1016/j.freeradbiomed.2023.01.003. Epub 2023 Jan 5. |
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Randomised double-blinded crossover
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Double-blinded
| De-xanthinated Cocoa Flavanol beverage mix | Dietary Supplement | Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk. |
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