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

The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk

Sponsors

Lead Sponsor: Quadram Institute Bioscience

Source Quadram Institute Bioscience
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.

Overall Status Completed
Start Date 2014-07-01
Completion Date 2016-10-01
Primary Completion Date 2016-10-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in systolic blood pressure from baseline Baseline, 2 hours and 4 weeks
Secondary Outcome
Measure 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
Enrollment 42
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Low Epicatechin and procyanidin

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

Arm Group Label: Low Epicatechin and procyanidin

Intervention Type: Dietary Supplement

Intervention Name: High Epicatechin and procyanidin

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

Arm Group Label: High Epicatechin and procyanidin

Intervention Type: Dietary Supplement

Intervention Name: High procyanidin

Description: No epicatechin and 130 mg procyanidins once daily for 28 days

Arm Group Label: High Procyanidin

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: Placebo control once daily for 28 days

Arm Group Label: Placebo

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.

Gender:

All

Minimum Age:

50 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Paul Dr Kroon, PhD Principal Investigator Quadram Institute Bioscience
Location
Facility: Institute of Food Research
Location Countries

United Kingdom

Verification Date

2015-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Low Epicatechin and procyanidin

Type: Experimental

Description: Low epicatechin and procyanidin doses

Label: High Epicatechin and procyanidin

Type: Experimental

Description: High epicatechin and procyanidin doses

Label: High Procyanidin

Type: Experimental

Description: High procyanidin only

Label: Placebo

Type: Placebo Comparator

Description: No epicatechin and procyanidin

Acronym FLAVASCULAR
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Double (Participant, Investigator)

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