NCT01097226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

March 31, 2010

Last Update Submit

March 5, 2013

Conditions

Healthy

Keywords

Dietary interventionbioavailabilityHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma pharmacokinetic curve for total epicatechin

    24 hours

Secondary Outcomes (2)

  • 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

Study Arms (1)

Apple flavanols

EXPERIMENTAL
Other: Apple extract delivering 70 mg epicatechinOther: Apple extract delivering 140 mg epicatechinOther: Apple granules delivering 70 mg epicatechinOther: Water delivering no epicatechin

Interventions

Apple extract delivering 70 mg epicatechinOTHER

Delivered as a flavoured water based beverage

Apple flavanols
Apple extract delivering 140 mg epicatechinOTHER

Delivered as a flavoured water based beverage

Apple flavanols
Apple granules delivering 70 mg epicatechinOTHER

Delivered as a puree

Apple flavanols
Water delivering no epicatechinOTHER

Delivered as flavoured water

Apple flavanols

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 45-70 years

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (1)

  • Saha S, Hollands W, Needs PW, Ostertag LM, de Roos B, Duthie GG, Kroon PA. Human O-sulfated metabolites of (-)-epicatechin and methyl-(-)-epicatechin are poor substrates for commercial aryl-sulfatases: implications for studies concerned with quantifying epicatechin bioavailability. Pharmacol Res. 2012 Jun;65(6):592-602. doi: 10.1016/j.phrs.2012.02.005. Epub 2012 Feb 25.

    PMID: 22373658DERIVED

MeSH Terms

Interventions

Catechin

Intervention Hierarchy (Ancestors)

ChromansBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFlavonoidsChromonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paul Kroon

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2010

First Posted

April 1, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

GB(1)