POLYMALUS: Bioavailability and Vascular Effects of Apple Polyphenols

Sponsor

Quadram Institute Bioscience (Other)

Overall Status

Completed

CT.gov ID

NCT01097226

Collaborator

Danisco (Industry), Coressence LTD (Other)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Bioavailability and Vascular Effects of Apple Polyphenols

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Area under the plasma pharmacokinetic curve for total epicatechin [24 hours]

Secondary Outcome Measures

Additional measures of bioavailability: Plasma Cmax, Tmax, half life and urinary excretion [24 hours]
Changes in levels of nitric Oxide metabolites as a surrogate measure of endothelial function after consumption of apple flavanols [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Institute of Food Research	Norwich	Norfolk	United Kingdom	NR4 7UA

Sponsors and Collaborators

Quadram Institute Bioscience
Danisco
Coressence LTD

Investigators

Principal Investigator: Paul Kroon, Quadram Institute Bioscience

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Quadram Institute Bioscience

ClinicalTrials.gov Identifier:

NCT01097226

Other Study ID Numbers:

IFR06-2009

First Posted:

Apr 1, 2010

Last Update Posted:

Mar 6, 2013

Last Verified:

Mar 1, 2013

Keywords provided by Quadram Institute Bioscience

Dietary intervention

bioavailability

Healthy volunteers

Study Results

No Results Posted as of Mar 6, 2013