The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- Quadram Institute Bioscience
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Changes in systolic blood pressure from baseline
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (CVD). The protective effect may be ascribed to compounds contained within these foods, called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine. There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the acute and chronic effects of apple derived flavanols on some risk markers for CVD.
Detailed Description
This study is a single arm randomized, 4-phase crossover design.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women ≥ 50 years of age
- •Systolic blood pressure 130 - 159 mmHg
Exclusion Criteria
- •History of cardiovascular events such as stroke, myocardial infarction trans- ischaemic attacks or peripheral vascular disease
- •Kidney or liver disease/problems
- •Asthmatics (unless no medication taken for 1 year - occasional use will be assessed on an individual basis)
- •Prescribed anti-hypertensive medication
- •HRT (unless the participant has used the therapy for ≥ 6 months)
- •Lipid lowering therapies e.g. statins
- •Other medications that may affect any of the study outcome measures e.g. vasodilators (this will be assessed on a case by case basis)
- •Current smoker (or stopped for less than 3 months)
- •Throat surgery or neck injury
- •Allergy to apples
Outcomes
Primary Outcomes
Changes in systolic blood pressure from baseline
Time Frame: Baseline, 2 hours and 4 weeks
Secondary Outcomes
- Changes in plasma lipid profile from baseline(Baseline and 4 weeks)
- Change in plasma endothelin-1 from baseline(Baseline and 4 weeks)
- Changes in plasma nitric oxide metabolites from baseline(Baseline, 2 hours and 4 weeks)
- Changes in blood glucose from baseline(Baseline and 4 weeks)
- Changes in pulse wave velocity from baseline(Baseline, 2 hours and 4 weeks)