Bioavailability and Vascular Effects of Apple Polyphenols

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-06-30

Brief Summary

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The main purpose of this study is to determine the oral bioavailability of flavanols (polyphenolic compounds) from apple granules and an apple extract delivered in a water based beverage at two different doses. We will also investigate the effects of apple flavanols on nitric oxide production.

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Detailed Description

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This study is a randomized four phase crossover trial investigating the bioavailability of apple flavanols and the effects on nitric oxide products, a surrogate marker for changes in endothelial function. Each test phase will comprise a 3 day period of intervention which will be identical in nature (except for the test product consumed) and separated by a minimum of 1 week. On days 1-3 of each test phase volunteers will consume a low flavanol diet. After consumption of the test product on the morning of day 2, blood and urine samples will be collected at regular intervals for the next 24h.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Apple flavanols

Group Type EXPERIMENTAL

Apple extract delivering 70 mg epicatechin

Intervention Type OTHER

Delivered as a flavoured water based beverage

Apple extract delivering 140 mg epicatechin

Intervention Type OTHER

Delivered as a flavoured water based beverage

Apple granules delivering 70 mg epicatechin

Intervention Type OTHER

Delivered as a puree

Water delivering no epicatechin

Intervention Type OTHER

Delivered as flavoured water

Interventions

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Apple extract delivering 70 mg epicatechin

Delivered as a flavoured water based beverage

Intervention Type OTHER

Apple extract delivering 140 mg epicatechin

Delivered as a flavoured water based beverage

Intervention Type OTHER

Apple granules delivering 70 mg epicatechin

Delivered as a puree

Intervention Type OTHER

Water delivering no epicatechin

Delivered as flavoured water

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 45-70 years

Exclusion Criteria

* Smokers (or have quit smoking less than 1 year ago)
* Regular prescribed medication (excluding some eye and skin medication that is judged not to affect study outcome)
* Non-prescribed medication that may affect the study data, e.g. aspirin. The use of non prescribed medications will be assessed on an individual basis.
* Dietary supplements or herbal remedies which may affect the study data unless the volunteer is willing to discontinue them for 1 month prior to starting study. (Please note that some supplements may not affect the study and this will be assessed on an individual basis).
* Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
* Diabetics
* Known cardiovascular disease
* Asthmatics (unless no medication taken for 1 year)
* Lactose Intolerance
* Pregnancy or have been pregnant within the last 12 months
* 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 mls.
* 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)
* Any person related to or living with any member of the study team
* Results of the clinical screening which indicate or are judged by the HNU Medical Advisor to be indicative of a health problem which could compromise the well-being of the volunteer if they participated or which could affect the study data.
* Alcohol consumption \> approximately 20 g alcohol/day (2.5 units/day)
* BMI \<19.5 or \> 35

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes