Effect of Apple Flavanols on Risk of Cardiovascular Disease

NCT00568152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2013-03-06

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Low PA apple puree

Golden Delicious apple puree 230grams consumed daily for 14 days

DIETARY_SUPPLEMENT

High PA apple puree

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

DRUG

Aspirin

75mg dispersable aspirin taken daily for 14 days

Sponsors & Collaborators

  • Quadram Institute Bioscience

    lead OTHER

Principal Investigators

  • Paul Kroon · Quadram Institute Bioscience

  • Amy Gasper · Quadram Institute Bioscience

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Completion
2008-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00568152 on ClinicalTrials.gov