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Completed

NCT Number: NCT01097226

Bioavailability and Vascular Effects of Apple Polyphenols

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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Key information

Conditions

Age range

45 year–70 year

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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Apple extract delivering 70 mg epicatechin

Other

Delivered as a flavoured water based beverage

Apple extract delivering 140 mg epicatechin

Other

Delivered as a flavoured water based beverage

Apple granules delivering 70 mg epicatechin

Other

Delivered as a puree

Water delivering no epicatechin

Other

Delivered as flavoured water

Primary outcomes

  1. Area under the plasma pharmacokinetic curve for total epicatechin

    Time frame: 24 hours

Secondary outcomes

  1. Additional measures of bioavailability: Plasma Cmax, Tmax, half life and urinary excretion

    Time frame: 24 hours

  2. Changes in levels of nitric Oxide metabolites as a surrogate measure of endothelial function after consumption of apple flavanols

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Quadram Institute Bioscience

Other

Collaborators

  • Coressence LTD
  • Danisco

Registry information

Acronym: POLYMALUS

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Apr 1, 2010
Registry last updated
Mar 6, 2013

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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