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

Study Overview
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Brief Summary
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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
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This study is a single arm randomized, 4-phase crossover design.

Official Title
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The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk

Conditions
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Blood Pressure

Intervention / Treatment
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* Dietary Supplement: Low Epicatechin and procyanidin
* Dietary Supplement: High Epicatechin and procyanidin
* Dietary Supplement: High procyanidin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Epicatechin and procyanidin<br>Low epicatechin and procyanidin doses | Dietary Supplement: Low Epicatechin and procyanidin<br>* 70 mg epicatechin and 65 mg procyanidins once daily for 28 days<br>|
| Experimental: High Epicatechin and procyanidin<br>High epicatechin and procyanidin doses | Dietary Supplement: High Epicatechin and procyanidin<br>* 140 mg epicatechin and 130 mg procyanidins once daily for 28 days<br>|
| Experimental: High Procyanidin<br>High procyanidin only | Dietary Supplement: High procyanidin<br>* No epicatechin and 130 mg procyanidins once daily for 28 days<br>|
| Placebo Comparator: Placebo<br>No epicatechin and procyanidin | Dietary Supplement: Placebo<br>* Placebo control once daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systolic blood pressure from baseline |  | Baseline, 2 hours and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Flavanols, Cardiovascular disease