HealthyNCT01130129
The Effects of Plant Bioactives on Platelet Function
A study testing Ex-vivo treatments with flavonoids in people with Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of cardiovascular disease and the protective effect may be due to polyphenolic compounds contained within these foods. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ex-vivo treatments with flavonoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females
- Aged 18 - 65 years.
- BMI > 19.5 and < 35
- Non-smokers
Who cannot join
- 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 during the Study period.
- Depressed or elevated blood pressure measurements (<90/50 or 95/50 if symptomatic or >160/100)
- Any person related to or living with any member of the study team
Show all 9Show fewer
- Diabetics
- Taking regular prescribed and/or non-prescribed medication (excluding oral contraceptive and HRT).
- Known bleeding disorders.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UA
About this study
Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of cardiovascular disease and the protective effect may be due to polyphenolic compounds contained within these foods. The mechanism by which polyphenols exert this effect is not clearly understood but research has focused on their potential to affect platelet function. The purpose of this study is to quantify the anti-clotting activity of a range of plant food extracts and component compounds.
Read the detailed description
A single sample of whole blood will be collected from 15 male or female volunteers aged between 18 and 65 years. After collection whole blood will be treated with a range of flavonoids to evaluate their effects on platelet function.
- Conditions
- Healthy
- Being tested
- Ex-vivo treatments with flavonoids
- Keywords
- Flavonoids, Platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex-vivo treatments with flavonoidsOther
Ex-vivo treatment of platelets with a range of flavonoids
| Study group | Role | What they receive |
|---|---|---|
| Ex-vivo treatment of platelets | Experimental | Ex-vivo treatment of platelets Receives: Other: Ex-vivo treatments with flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of flavonoids that exert a significant anti-clotting effect
Measured: within 4hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Paul Kroon, phD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130129
- Sponsor's protocol ID
- IFR02/2009
- Status last verified
- Mar 2013
- First submitted
- 24 May 2010
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
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
- The Effects of Plant Bioactives on Platelet Function
- ClinicalTrials.gov ID
- NCT01130129
- Acronym / sponsor ID
- IFR02/2009
- Conditions
- Healthy
- Keywords
- Flavonoids, Platelets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 May 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.
Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of cardiovascular disease and the protective effect may be due to polyphenolic compounds contained within these foods. The mechanism by which polyphenols exert this effect is not clearly understood but research has focused on their potential to affect platelet function. The purpose of this study is to quantify the anti-clotting activity of a range of plant food extracts and component compounds.
Detailed description
A single sample of whole blood will be collected from 15 male or female volunteers aged between 18 and 65 years. After collection whole blood will be treated with a range of flavonoids to evaluate their effects on platelet function.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ex-vivo treatment of platelets | Experimental | Other: Ex-vivo treatments with flavonoidsEx-vivo treatment of platelets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females
- Aged 18 - 65 years.
- BMI > 19.5 and < 35
- Non-smokers
Key exclusion criteria (9 listed)
- 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 during the Study period.
- Depressed or elevated blood pressure measurements (<90/50 or 95/50 if symptomatic or >160/100)
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 |
|---|---|---|
| Ex-vivo treatments with flavonoidsEx-vivo treatment of platelets with a range of flavonoids | Other | Ex-vivo treatment of platelets |
Primary outcome
Identification of flavonoids that exert a significant anti-clotting effect
Time frame: within 4hours
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.
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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, phD 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 Ex-vivo treatments with flavonoids 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 4 inclusion and 9 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?
Identification of flavonoids that exert a significant anti-clotting effect (time frame: within 4hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.