Clinical trial NCT02013856: The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk (FLAVASCULAR Study)
Official title: The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Blood pressure
Flavanols
Cardiovascular disease
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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
* 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.

Primary outcomes:
measure: Changes in systolic blood pressure from baseline
timeFrame: Baseline, 2 hours and 4 weeks
Secondary outcomes:
measure: Changes in plasma lipid profile from baseline
timeFrame: Baseline and 4 weeks
measure: Change in plasma endothelin-1 from baseline
timeFrame: Baseline and 4 weeks
measure: Changes in plasma nitric oxide metabolites from baseline
timeFrame: Baseline, 2 hours and 4 weeks
measure: Changes in blood glucose from baseline
timeFrame: Baseline and 4 weeks
measure: Changes in pulse wave velocity from baseline
timeFrame: Baseline, 2 hours and 4 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Institute of Food Research
state: Norfolk
Study officials:
affiliation: Quadram Institute Bioscience
name: Paul Dr Kroon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hollands WJ, Tapp H, Defernez M, Perez Moral N, Winterbone MS, Philo M, Lucey AJ, Kiely ME, Kroon PA. Lack of acute or chronic effects of epicatechin-rich and procyanidin-rich apple extracts on blood pressure and cardiometabolic biomarkers in adults with moderately elevated blood pressure: a randomized, placebo-controlled crossover trial. Am J Clin Nutr. 2018 Nov 1;108(5):1006-1014. doi: 10.1093/ajcn/nqy139.