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

NCT02013856 | Completed

• 1 other identifier: IFR05/2013
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Blood pressure; Flavanols; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Changes in systolic blood pressure from baseline

  Baseline, 2 hours and 4 weeks

Secondary Outcomes (5)

• 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

Study Arms (4)

Low Epicatechin and procyanidin

EXPERIMENTAL

Low epicatechin and procyanidin doses

Dietary Supplement: Low Epicatechin and procyanidin

High Epicatechin and procyanidin

EXPERIMENTAL

High epicatechin and procyanidin doses

Dietary Supplement: High Epicatechin and procyanidin

High Procyanidin

EXPERIMENTAL

High procyanidin only

Dietary Supplement: High procyanidin

Placebo

PLACEBO COMPARATOR

No epicatechin and procyanidin

Dietary Supplement: Placebo

Interventions

Low Epicatechin and procyanidin DIETARY_SUPPLEMENT

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

Low Epicatechin and procyanidin

High Epicatechin and procyanidin DIETARY_SUPPLEMENT

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

High Epicatechin and procyanidin

High procyanidin DIETARY_SUPPLEMENT

No epicatechin and 130 mg procyanidins once daily for 28 days

High Procyanidin

Placebo DIETARY_SUPPLEMENT

Placebo control once daily for 28 days

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 50 years of age
• Systolic blood pressure 130 - 159 mmHg

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quadram Institute Bioscience: lead

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30475960 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

procyanidin

Study Officials

• Paul Dr Kroon, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 17, 2013
• Study Start: July 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2015-11

Locations

GB (1)