HealthyPOLYMALUSNCT01097226
Bioavailability and Vascular Effects of Apple Polyphenols
A study testing Apple extract delivering 70 mg epicatechin, Apple extract delivering 140 mg epicatechin and Apple granules delivering 70 mg epicatechin in people with Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Apple extract delivering 70 mg epicatechin, Apple extract delivering 140 mg epicatechin and Apple granules delivering 70 mg epicatechin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 45-70 years
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UA
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Apple extract delivering 70 mg epicatechin, Apple extract delivering 140 mg epicatechin, Apple granules delivering 70 mg epicatechin, Water delivering no epicatechin
- Keywords
- Dietary intervention, bioavailability, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple extract delivering 70 mg epicatechinOther
Delivered as a flavoured water based beverage
Apple extract delivering 140 mg epicatechinOther
Delivered as a flavoured water based beverage
Apple granules delivering 70 mg epicatechinOther
Delivered as a puree
Water delivering no epicatechinOther
Delivered as flavoured water
| Study group | Role | What they receive |
|---|---|---|
| Apple flavanols | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma pharmacokinetic curve for total epicatechin
Measured: 24 hours
Secondary outcomes (2)
Additional measures of bioavailability: Plasma Cmax, Tmax, half life and urinary excretion
Measured: 24 hours
Changes in levels of nitric Oxide metabolites as a surrogate measure of endothelial function after consumption of apple flavanols
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Danisco, Coressence LTD
- Responsible party
- Sponsor
- Investigators
- Paul Kroon, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097226
- Sponsor's protocol ID
- IFR06-2009
- Acronym
- POLYMALUS
- Status last verified
- Mar 2013
- First submitted
- 31 Mar 2010
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22373658
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Vascular Effects of Apple Polyphenols
- ClinicalTrials.gov ID
- NCT01097226
- Acronym / sponsor ID
- POLYMALUS / IFR06-2009
- Conditions
- Healthy
- Keywords
- Dietary intervention, bioavailability, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Danisco, Coressence LTD
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apple flavanols | Experimental | 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 |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged 45-70 years
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple extract delivering 70 mg epicatechinDelivered as a flavoured water based beverage | Other | Apple flavanols |
| Apple extract delivering 140 mg epicatechinDelivered as a flavoured water based beverage | Other | Apple flavanols |
| Apple granules delivering 70 mg epicatechinDelivered as a puree | Other | Apple flavanols |
| Water delivering no epicatechinDelivered as flavoured water | Other | Apple flavanols |
Primary outcome
Area under the plasma pharmacokinetic curve for total epicatechin
Time frame: 24 hours
2 secondary outcomes
Additional measures of bioavailability: Plasma Cmax, Tmax, half life and urinary excretion
Time frame: 24 hours
Changes in levels of nitric Oxide metabolites as a surrogate measure of endothelial function after consumption of apple flavanols
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
- Derived from this study: PubMed 22373658Saha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Kroon principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple extract delivering 70 mg epicatechin, Apple extract delivering 140 mg epicatechin and Apple granules delivering 70 mg epicatechin in people with Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma pharmacokinetic curve for total epicatechin (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.