drugset / Trial / NCT00568152
Effect of Apple Flavanols on Risk of Cardiovascular Disease
RandomizedCrossoverSingle-blindPrevention
Summary
A randomised three period cross over trial will be carried out in adults (19-64 years) to assess the acute and chronic effects of a large dose of apple procyanidin (PA) compared with a low dose of apple PA (negative control) and aspirin (positive control), on platelet function and other risk factors of cardiovascular disease. Platelet function will be assessed prior to a run in diet and at the start and end of each intervention. Volunteers will be assigned at random to consume 230grams of low PA apple puree or high PA apple puree or aspirin (75mg) each day for 2 weeks followed by a minimum 14 day wash out. Hypothesis: Consuming apple PA reduces platelet function consistent with reduced risk of cardiovascular disease.
Timeline
- Start
- 2006-05
- Primary completion
- —
- Completion
- 2008-05
Publications
- Background Ambrose JA, Barua RS. The pathophysiology of cigarette smoking and cardiovascular disease: an update. J Am Coll Cardiol. 2004 May 19;43(10):1731-7. doi: 10.1016/j.jacc.2003.12.047.
- Background Donovan JL, Manach C, Rios L, Morand C, Scalbert A, Remesy C. Procyanidins are not bioavailable in rats fed a single meal containing a grapeseed extract or the procyanidin dimer B3. Br J Nutr. 2002 Apr;87(4):299-306. doi: 10.1079/bjnbjn2001517.
- Background DuPont MS, Day AJ, Bennett RN, Mellon FA, Kroon PA. Absorption of kaempferol from endive, a source of kaempferol-3-glucuronide, in humans. Eur J Clin Nutr. 2004 Jun;58(6):947-54. doi: 10.1038/sj.ejcn.1601916.
- Background Gimenez R, Cabrera C, Olalla M, Ruiz MD, Lopez MC. Ascorbic acid in diet supplements: loss in the manufacturing process and storage. Int J Food Sci Nutr. 2002 Nov;53(6):509-18. doi: 10.1080/09637480220164352.
- Background Heiss C, Kleinbongard P, Dejam A, Perre S, Schroeter H, Sies H, Kelm M. Acute consumption of flavanol-rich cocoa and the reversal of endothelial dysfunction in smokers. J Am Coll Cardiol. 2005 Oct 4;46(7):1276-83. doi: 10.1016/j.jacc.2005.06.055.
- Background Holt RR, Lazarus SA, Sullards MC, Zhu QY, Schramm DD, Hammerstone JF, Fraga CG, Schmitz HH, Keen CL. Procyanidin dimer B2 [epicatechin-(4beta-8)-epicatechin] in human plasma after the consumption of a flavanol-rich cocoa. Am J Clin Nutr. 2002 Oct;76(4):798-804. doi: 10.1093/ajcn/76.4.798.
- Background McKenzie ME, Malinin AI, Bell CR, Dzhanashvili A, Horowitz ED, Oshrine BR, Atar D, Serebruany VL. Aspirin inhibits surface glycoprotein IIb/IIIa, P-selectin, CD63, and CD107a receptor expression on human platelets. Blood Coagul Fibrinolysis. 2003 Apr;14(3):249-53. doi: 10.1097/01.mbc.0000046182.72384.ab.
- Background Tsang C, Auger C, Mullen W, Bornet A, Rouanet JM, Crozier A, Teissedre PL. The absorption, metabolism and excretion of flavan-3-ols and procyanidins following the ingestion of a grape seed extract by rats. Br J Nutr. 2005 Aug;94(2):170-81. doi: 10.1079/bjn20051480.
- Background Tsiara S, Elisaf M, Jagroop IA, Mikhailidis DP. Platelets as predictors of vascular risk: is there a practical index of platelet activity? Clin Appl Thromb Hemost. 2003 Jul;9(3):177-90. doi: 10.1177/107602960300900301.
- Background Williamson G, Manach C. Bioavailability and bioefficacy of polyphenols in humans. II. Review of 93 intervention studies. Am J Clin Nutr. 2005 Jan;81(1 Suppl):243S-255S. doi: 10.1093/ajcn/81.1.243S.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 75 mg | — |