NCT00568152

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

First QC Date

December 4, 2007

Last Update Submit

March 5, 2013

Conditions

Cardiovascular Disease

Keywords

ApplesDietary interventionProcyanidins

Outcome Measures

Primary Outcomes (1)

  • The aim of this trial is to investigate the effect of consuming apple PA on platelet function.

    16 weeks

Secondary Outcomes (1)

  • To measure the bioavailability of PA and metabolites from two well characterised apple purees providing a low and high dose of PA.

    16 weeks

Study Arms (3)

Low PA apple puree

EXPERIMENTAL

230grams of low PA apple puree (Golden Delicious) consumed daily for 14 days.

Dietary Supplement: Low PA apple puree

High PA apple puree

EXPERIMENTAL

High PA apple puree (Mitchalin) 230grams consumed daily for 14 days

Dietary Supplement: High PA apple puree

Aspirin

PLACEBO COMPARATOR

75mg dispersable aspirin taken daily for 14 days

Drug: Aspirin

Interventions

Low PA apple pureeDIETARY_SUPPLEMENT

Golden Delicious apple puree 230grams consumed daily for 14 days

Low PA apple puree
High PA apple pureeDIETARY_SUPPLEMENT

High PA apple puree (Mitchalin) consumed daily for 14 days

High PA apple puree
AspirinDRUG

75mg dispersable aspirin taken daily for 14 days

Aspirin

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male and female aged 19-64

You may not qualify if:

  • Smokers, very low or high pressure (\<90/50 or \<95/55 if symptomatic or \>160/100), BMI \<18.5 or \>35, pregnant or have been pregnant in last 12 months, diagnosed with gastrointestinal disease, history of ulcers and gastrointestinal bleeding, diagnosed with a long term illness requiring active treatment, history of stroke, on regularly prescribed medication known to have a profound effect on cardiovascular disease risk factors, using non steroidal anti inflammatory cream, sufferers of asthma or hay fever, known intolerance to aspirin, allergic to apples or birch pollen, regular use of aspirin, antacids or laxatives, unwillingness to discontinue specific dietary or herbal supplements less than 1 month prior to the start of the study, blood donation within 16 weeks of the first study sample, antibiotic use within 4 weeks prior to starting the study, those who receive or plan to receive any type of immunisation within 4 weeks of the start of the study, parallel participation in any other research project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institue of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (10)

  • 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.

    PMID: 15145091BACKGROUND

  • 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.

    PMID: 12064339BACKGROUND

  • 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.

    PMID: 15164116BACKGROUND

  • 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.

    PMID: 12590746BACKGROUND

  • 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.

    PMID: 16198843BACKGROUND

  • 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.

    PMID: 12324293BACKGROUND

  • 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.

    PMID: 12695747BACKGROUND

  • 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.

    PMID: 16115350BACKGROUND

  • 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.

    PMID: 14507105BACKGROUND

  • 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.

    PMID: 15640487BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Paul Kroon

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

  • Amy Gasper

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

May 1, 2006

Study Completion

May 1, 2008

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

GB(1)