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| ID | Type | Description | Link |
|---|---|---|---|
| 311497-I | Other Identifier | UC Davis |
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Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of the consumption of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study was followed by a second study that aimed at investigating the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocoa Flavanol intake escalation | Experimental | Ingestion of increasing number of capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process (500 mg of cocoa flavanols/capsule) during 6 weeks followed by a 2 week of washout (no capsule intake) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mars Cocoa Extract Capsules | Dietary Supplement | Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process, providing 500 mg of cocoa flavanols per capsule: 1000 mg of cocoa flavanols consumed daily during week 1 and 2, 1500 mg of cocoa flavanols consumed daily during week 3 and 4, and 2000 mg of cocoa flavanols consumed daily during week 5 and 6, and no capsule consumed (washout) during week 7 and 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Blood pressure will be measured using standard techniques. | Baseline (day 0) and 14, 28, 42 and 56 days after intervention |
| Change in platelet function | Platelet function will be determined using the PFA-100® analyzer (Dade Behring International, Miami, FL) with collagen-epinephrine (CEPI)- and collagen-ADP (CADP) stimulation. | Baseline and 14, 28, 42 and 56 days after intervention |
| Change in metabolic parameters in blood | Metabolic parameters determined in blood included: comprehensive metabolic panel, liver panel and cell blood counting. | Baseline (day 0) and 14, 28, 42 and 56 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma concentration of cocoa flavanol metabolites | Cocoa flavanol metabolites in plasma include: structurally related (-)-epicatechin metabolites and 5-(3,4-dihydroxyphenyl)-4-valerolactone metabolites | Baseline (day 0) and 14, 28, 42 and 56 days after intervention |
| Change in plasma concentration of methylxanthines |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl L Keen, PhD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20854838 | Background | Schroeter H, Heiss C, Spencer JP, Keen CL, Lupton JR, Schmitz HH. Recommending flavanols and procyanidins for cardiovascular health: current knowledge and future needs. Mol Aspects Med. 2010 Dec;31(6):546-57. doi: 10.1016/j.mam.2010.09.008. Epub 2010 Sep 18. | |
| 26537937 | Derived | Ottaviani JI, Balz M, Kimball J, Ensunsa JL, Fong R, Momma TY, Kwik-Uribe C, Schroeter H, Keen CL. Safety and efficacy of cocoa flavanol intake in healthy adults: a randomized, controlled, double-masked trial. Am J Clin Nutr. 2015 Dec;102(6):1425-35. doi: 10.3945/ajcn.115.116178. Epub 2015 Nov 4. |
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Methylxanthines determined in plasma include: caffeine, theobromine, paraxanthine and theophylline |
| Baseline (day 0) and 14, 28, 42 and 56 days after intervention |