The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk (FLAVASCULAR Study)

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: High Epicatechin and procyanidin; Dietary Supplement: Low Epicatechin and procyanidin; Dietary Supplement: High procyanidin

• Registration Number: NCT02013856
• Lead Sponsor: Quadram Institute Bioscience

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.

Study Timeline

• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Study Start: 2014-07
• Status Verified: 2015-11
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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
• Diabetes
• 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
• Consumption of fish oil supplements unless willing to discontinue them up for 4 weeks preceding the start of the study and for the duration of the study. (All other supplements will be assessed on a case by case basis)
• Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
• Parallel participation in another research project which involves dietary intervention
• Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 ml.
• Has donated or intends to donate blood within 16 weeks prior to or during the study period.
• Depressed or elevated blood pressure measurements (<90/50 or 95/55 if symptomatic or >160/100 (mmHg)) during the course of the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	No epicatechin and procyanidin
High Epicatechin and procyanidin	High Epicatechin and procyanidin	High epicatechin and procyanidin doses
Low Epicatechin and procyanidin	Low Epicatechin and procyanidin	Low epicatechin and procyanidin doses
High Procyanidin	High procyanidin	High procyanidin only

Primary Outcome Measures

Name	Time	Method
Changes in systolic blood pressure from baseline	Baseline, 2 hours and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in plasma lipid profile 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
Change in plasma endothelin-1 from baseline	Baseline and 4 weeks

Trial Locations

Locations (1)

Institute of Food Research; 🇬🇧 Norwich, Norfolk, United Kingdom