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

Quadram Institute Bioscience

Status: Completed

Conditions: Blood Pressure

Treatments: Dietary Supplement: Low Epicatechin and procyanidin; Dietary Supplement: High procyanidin; Dietary Supplement: Placebo; Dietary Supplement: High Epicatechin and procyanidin

Study type: Interventional

Funder types: Other

Identifiers

NCT02013856

IFR05/2013

Details and patient eligibility

About

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.

Full description

This study is a single arm randomized, 4-phase crossover design.

Enrollment: 42 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 4 patient groups, including a placebo group

Low Epicatechin and procyanidin

Experimental group

Description:

Low epicatechin and procyanidin doses

Treatment:

Dietary Supplement: Low Epicatechin and procyanidin

High Epicatechin and procyanidin

Experimental group

Description:

High epicatechin and procyanidin doses

Treatment:

Dietary Supplement: High Epicatechin and procyanidin

High Procyanidin

Experimental group

Description:

High procyanidin only

Treatment:

Dietary Supplement: High procyanidin

Placebo

Placebo Comparator group

Description:

No epicatechin and procyanidin

Treatment:

Dietary Supplement: Placebo