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

Blood Pressure Clinical Trial

— FLAVASCULAR  

Official title:

The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013856
• Other study ID #: IFR05/2013
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: December 1, 2016
• Start date: July 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2015
• Source: Institute of Food Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Low Epicatechin and procyanidin
70 mg epicatechin and 65 mg procyanidins once daily for 28 days
• High Epicatechin and procyanidin
140 mg epicatechin and 130 mg procyanidins once daily for 28 days
• High procyanidin
No epicatechin and 130 mg procyanidins once daily for 28 days
• Placebo
Placebo control once daily for 28 days

Locations

Country	Name	City	State
United Kingdom	Institute of Food Research	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Food Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in systolic blood pressure from baseline		Baseline, 2 hours and 4 weeks	No
Secondary	Changes in plasma lipid profile from baseline		Baseline and 4 weeks	No
Secondary	Change in plasma endothelin-1 from baseline		Baseline and 4 weeks	No
Secondary	Changes in plasma nitric oxide metabolites from baseline		Baseline, 2 hours and 4 weeks	No
Secondary	Changes in blood glucose from baseline		Baseline and 4 weeks	No
Secondary	Changes in pulse wave velocity from baseline		Baseline, 2 hours and 4 weeks	No