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Completed

NCT Number: NCT02013856

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Epicatechin and procyanidin

Dietary Supplement

70 mg epicatechin and 65 mg procyanidins once daily for 28 days

High Epicatechin and procyanidin

Dietary Supplement

140 mg epicatechin and 130 mg procyanidins once daily for 28 days

High procyanidin

Dietary Supplement

No epicatechin and 130 mg procyanidins once daily for 28 days

Placebo

Dietary Supplement

Placebo control once daily for 28 days

Primary outcomes

  1. Changes in systolic blood pressure from baseline

    Time frame: Baseline, 2 hours and 4 weeks

Secondary outcomes

  1. Changes in plasma lipid profile from baseline

    Time frame: Baseline and 4 weeks

  2. Change in plasma endothelin-1 from baseline

    Time frame: Baseline and 4 weeks

  3. Changes in plasma nitric oxide metabolites from baseline

    Time frame: Baseline, 2 hours and 4 weeks

  4. Changes in blood glucose from baseline

    Time frame: Baseline and 4 weeks

  5. Changes in pulse wave velocity from baseline

    Time frame: Baseline, 2 hours and 4 weeks

Sponsors and collaborators

Lead sponsor

Quadram Institute Bioscience

Other

Registry information

Official study title

The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk

Acronym: FLAVASCULAR

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2013
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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