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Bioavailability and Vascular Effects of Apple Polyphenols (POLYMALUS)

This study has been completed.
Sponsor:
Collaborators:
Danisco
Coressence LTD
Information provided by (Responsible Party):
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT01097226
First received: March 31, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Apple extract delivering 70 mg epicatechin
Other: Apple extract delivering 140 mg epicatechin
Other: Apple granules delivering 70 mg epicatechin
Other: Water delivering no epicatechin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Bioavailability and Vascular Effects of Apple Polyphenols

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
Drug Information available for: Cianidanol
U.S. FDA Resources

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Area under the plasma pharmacokinetic curve for total epicatechin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional measures of bioavailability: Plasma Cmax, Tmax, half life and urinary excretion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Changes in levels of nitric Oxide metabolites as a surrogate measure of endothelial function after consumption of apple flavanols [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apple flavanols Other: Apple extract delivering 70 mg epicatechin
Delivered as a flavoured water based beverage
Other: Apple extract delivering 140 mg epicatechin
Delivered as a flavoured water based beverage
Other: Apple granules delivering 70 mg epicatechin
Delivered as a puree
Other: Water delivering no epicatechin
Delivered as flavoured water

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097226

Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Institute of Food Research
Danisco
Coressence LTD
Investigators
Principal Investigator: Paul Kroon Institute of Food Research
  More Information

No publications provided by Institute of Food Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Institute of Food Research
ClinicalTrials.gov Identifier: NCT01097226     History of Changes
Other Study ID Numbers: IFR06-2009
Study First Received: March 31, 2010
Last Updated: March 5, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Food Research:
Dietary intervention
bioavailability
Healthy volunteers

ClinicalTrials.gov processed this record on May 23, 2013