Effect of Apple Flavanols on Risk of Cardiovascular Disease

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute of Food Research; Quadram Institute Bioscience
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• male and female aged 19-64

Exclusion Criteria:

• 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.