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Clinical Trials/NCT02013856
NCT02013856
Completed
Not Applicable

The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk

Quadram Institute Bioscience1 site in 1 country42 target enrollmentJuly 2014
ConditionsBlood Pressure

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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