Cardiovascular Disease Risk ReductionFASTCHECKNCT01530893
Flavonoids, Blood Pressure and Blood Vessel Function
A study testing Flavanone - supplement, Flavanone - food and Isoflavone - supplement in people with Cardiovascular Disease Risk Reduction, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
The primary aim of this placebo-controlled study is to determine whether flavonoids beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated cardiovascular risk. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease Risk Reduction
- What is being tested?
- Flavanone - supplement, Flavanone - food and Isoflavone - supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Dec 2013
- 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 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males
- 50 to 75 years old
- At elevated risk of CV disease
- Screening blood pressure of < 160/90mmHg (at rest)
- Successful biochemical, haematological and urinalysis assessment at screening (as judged by clinical advisor)
Who cannot join
- Current smokers, or ex-smokers ceasing < 3 months ago
- Subjects with existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures (as judged by clinical advisor)
- Those with known allergies to the intervention treatments
- Those unprepared to adhere to dietary restrictions during the trial
- Parallel participation in another research project which involves concurrent dietary intervention and/or sampling of biological fluids/material
- Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
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- Taking flavonoid containing food / dietary supplements likely to affect the study results
- Prescribed lipid lowering, hypertension, vasodilators (e.g. Viagra) or antibiotic medication
- Unsatisfactory biochemical, haematological or urinary assessment at screening, indicating abnormal; renal or liver function, full blood profile, impaired glucose handling, deranged lipids or measurements considered to be counter indicative of the study by the clinical advisor
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Nutrition, Norwich Medical School
Norwich, Norfolk, NR4 7TJ
About this study
Official title: Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?
The primary aim of this placebo-controlled study is to determine whether flavonoids beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated cardiovascular risk.
The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we will assess the effects of the food matrix, and aspects of isoflavone metabolism.
Read the detailed description
The study population will be healthy males (aged 50-75 years) at elevated risk of cardiovascular (CV) disease.
A target of 60 participants will be required to complete the study and a total of 70 subjects will be targeted (n=70 subjects * ~85% anticipated completion rate = 60 subjects to complete the study).
This placebo-controlled study will test the relative efficacy of 4 different flavonoid sub-classes ((i) flavan-3-ol, (ii) anthocyanin, (iii) flavanone and (iv) isoflavone).
Accordingly, subjects will be randomised to one of the four flavonoid study groups ((i) to (iv) outlined above), and then will consume each of the following treatments in random order:
- dietary flavonoid + placebo supplement
- placebo food + commercially available/produced flavonoid supplement
- placebo food + placebo supplement
Additionally, an isoflavone metabolite will be fed to establish potential vascular effects.
Each sub-class will be assessed separately and a 1 week wash-out period between treatments will be observed.
At each assessment visit, vascular function will be assessed pre- and post-intervention, with subsequent assessments made to coincide with anticipated peak plasma concentrations.
Dietary intake will be monitored during the study and participants will be required to adhere to a range of dietary and lifestyle restrictions within 3 days of each assessment to reduce potential confounding of the data assessment of interest.
A standard battery of vascular function tests will be performed on all intervention groups, with each assessment visit performed in an identical manner.
- Conditions
- Cardiovascular Disease Risk Reduction
- Being tested
- Flavanone - supplement, Flavanone - food, Flavanone - placebo, Isoflavone - supplement, Isoflavone - food
- Keywords
- flavonoids, vascular function, randomised controlled trial, placebo controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanone - supplementDietary supplement
acute single optimal dose
Flavanone - foodOther
acute single dose
Flavanone - placeboOther
acute single dose (flavanone free)
Isoflavone - supplementDietary supplement
acute single optimal dose
Isoflavone - foodOther
acute single optimal dose
Isoflavone - placeboOther
acute single dose (isoflavone free)
Isoflavone - metabolite supplementDietary supplement
acute single optimal dose of commercial product
Flavan-3-ol - supplementDietary supplement
acute single optimal dose
Flavan-3-ol - foodOther
acute single optimal dose
Flavan-3-ol - placeboOther
acute single dose (flavan-3-ol free)
Anthocyanin - supplementDietary supplement
acute single optimal dose
Anthocyanin - foodOther
acute single optimal dose
Anthocyanin - placeboOther
acute single dose (anthocyanin free)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group A: flavanones | Experimental | All experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest. Receives: Dietary Supplement: Flavanone - supplement; Other: Flavanone - food; Other: Flavanone - placebo |
| Intervention group B: isoflavones | Experimental | All experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest. Receives: Dietary Supplement: Isoflavone - supplement; Other: Isoflavone - food; Other: Isoflavone - placebo; Dietary Supplement: Isoflavone - metabolite supplement |
| Intervention group C: Flavan-3-ols | Experimental | All experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest. Receives: Dietary Supplement: Flavan-3-ol - supplement; Other: Flavan-3-ol - food; Other: Flavan-3-ol - placebo |
| Intervention group D: Anthocyanins | Experimental | All experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest. Receives: Dietary Supplement: Anthocyanin - supplement; Other: Anthocyanin - food; Other: Anthocyanin - placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration.
Assessment of vascular function
Measured: acute postprandial; up to 24 hours, dependent on flavonoid sub-classification studied
Secondary outcomes (1)
Differences in effects of flavonoids introduced by food matrix
Measured: acute postprandial; up to 24 hours dependent on flavonoid sub-classification studied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease Risk ReductionStudies 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aedin Cassidy, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530893
- Sponsor's protocol ID
- FASTCHECK
- Acronym
- FASTCHECK
- Status last verified
- Feb 2014
- First submitted
- 1 Feb 2012
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hazim S, Curtis PJ, Schar MY, Ostertag LM, Kay CD, Minihane AM, Cassidy A. Acute benefits of the microbial-derived isoflavone metabolite equol on arterial stiffness in men prospectively recruited according to equol producer phenotype: a double-blind randomized controlled trial. Am J Clin Nutr. 2016 Mar;103(3):694-702. doi: 10.3945/ajcn.115.125690. Epub 2016 Feb 3.
PubMed 26843154Schar MY, Curtis PJ, Hazim S, Ostertag LM, Kay CD, Potter JF, Cassidy A. Orange juice-derived flavanone and phenolic metabolites do not acutely affect cardiovascular risk biomarkers: a randomized, placebo-controlled, crossover trial in men at moderate risk of cardiovascular disease. Am J Clin Nutr. 2015 May;101(5):931-8. doi: 10.3945/ajcn.114.104364. Epub 2015 Mar 18.
PubMed 25788001
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?
- ClinicalTrials.gov ID
- NCT01530893
- Acronym / sponsor ID
- FASTCHECK / FASTCHECK
- Conditions
- Cardiovascular Disease Risk Reduction
- Keywords
- flavonoids, vascular function, randomised controlled trial, placebo controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Feb 2012 (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 primary aim of this placebo-controlled study is to determine whether flavonoids beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated cardiovascular risk.
The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we will assess the effects of the food matrix, and aspects of isoflavone metabolism.
Detailed description
The study population will be healthy males (aged 50-75 years) at elevated risk of cardiovascular (CV) disease.
A target of 60 participants will be required to complete the study and a total of 70 subjects will be targeted (n=70 subjects * ~85% anticipated completion rate = 60 subjects to complete the study).
This placebo-controlled study will test the relative efficacy of 4 different flavonoid sub-classes ((i) flavan-3-ol, (ii) anthocyanin, (iii) flavanone and (iv) isoflavone).
Accordingly, subjects will be randomised to one of the four flavonoid study groups ((i) to (iv) outlined above), and then will consume each of the following treatments in random order:
- dietary flavonoid + placebo supplement
- placebo food + commercially available/produced flavonoid supplement
- placebo food + placebo supplement
Additionally, an isoflavone metabolite will be fed to establish potential vascular effects.
Each sub-class will be assessed separately and a 1 week wash-out period between treatments will be observed.
At each assessment visit, vascular function will be assessed pre- and post-intervention, with subsequent assessments made to coincide with anticipated peak plasma concentrations.
Dietary intake will be monitored during the study and participants will be required to adhere to a range of dietary and lifestyle restrictions within 3 days of each assessment to reduce potential confounding of the data assessment of interest.
A standard battery of vascular function tests will be performed on all intervention groups, with each assessment visit performed in an identical manner.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group A: flavanones | Experimental | Dietary Supplement: Flavanone - supplement, Other: Flavanone - food, Other: Flavanone - placeboAll experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest. |
| Intervention group B: isoflavones | Experimental | Dietary Supplement: Isoflavone - supplement, Other: Isoflavone - food, Other: Isoflavone - placebo, Dietary Supplement: Isoflavone - metabolite supplementAll experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest. |
| Intervention group C: Flavan-3-ols | Experimental | Dietary Supplement: Flavan-3-ol - supplement, Other: Flavan-3-ol - food, Other: Flavan-3-ol - placeboAll experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest. |
| Intervention group D: Anthocyanins | Experimental | Dietary Supplement: Anthocyanin - supplement, Other: Anthocyanin - food, Other: Anthocyanin - placeboAll experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males
- 50 to 75 years old
- At elevated risk of CV disease
- Screening blood pressure of < 160/90mmHg (at rest)
- Successful biochemical, haematological and urinalysis assessment at screening (as judged by clinical advisor)
Key exclusion criteria (9 listed)
- Current smokers, or ex-smokers ceasing < 3 months ago
- Subjects with existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures (as judged by clinical advisor)
- Those with known allergies to the intervention treatments
- Those unprepared to adhere to dietary restrictions during the trial
- Parallel participation in another research project which involves concurrent dietary intervention and/or sampling of biological fluids/material
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 |
|---|---|---|
| Flavanone - supplementacute single optimal dose | Dietary supplement | Intervention group A: flavanones |
| Flavanone - foodacute single dose | Other | Intervention group A: flavanones |
| Flavanone - placeboacute single dose (flavanone free) | Other | Intervention group A: flavanones |
| Isoflavone - supplementacute single optimal dose | Dietary supplement | Intervention group B: isoflavones |
| Isoflavone - foodacute single optimal dose | Other | Intervention group B: isoflavones |
| Isoflavone - placeboacute single dose (isoflavone free) | Other | Intervention group B: isoflavones |
| Isoflavone - metabolite supplementacute single optimal dose of commercial product | Dietary supplement | Intervention group B: isoflavones |
| Flavan-3-ol - supplementacute single optimal dose | Dietary supplement | Intervention group C: Flavan-3-ols |
| Flavan-3-ol - foodacute single optimal dose | Other | Intervention group C: Flavan-3-ols |
| Flavan-3-ol - placeboacute single dose (flavan-3-ol free) | Other | Intervention group C: Flavan-3-ols |
| Anthocyanin - supplementacute single optimal dose | Dietary supplement | Intervention group D: Anthocyanins |
| Anthocyanin - foodacute single optimal dose | Other | Intervention group D: Anthocyanins |
| Anthocyanin - placeboacute single dose (anthocyanin free) | Other | Intervention group D: Anthocyanins |
Primary outcome
Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration.
Time frame: acute postprandial; up to 24 hours, dependent on flavonoid sub-classification studied
Assessment of vascular function
1 secondary outcome
Differences in effects of flavonoids introduced by food matrix
Time frame: acute postprandial; up to 24 hours dependent on flavonoid sub-classification studied
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 28 Feb 2014.
- Derived from this study: PubMed 26843154Hazim S, Curtis PJ, Schar MY, Ostertag LM, Kay CD, Minihane AM, Cassidy A. Acute benefits of the microbial-derived isoflavone metabolite equol on arterial stiffness in men prospectively recruited according to equol producer phenotype: a double-blind randomized controlled trial. Am J Clin Nutr. 2016 Mar;103(3):694-702. doi: 10.3945/ajcn.115.125690. Epub 2016 Feb 3.
- Derived from this study: PubMed 25788001Schar MY, Curtis PJ, Hazim S, Ostertag LM, Kay CD, Potter JF, Cassidy A. Orange juice-derived flavanone and phenolic metabolites do not acutely affect cardiovascular risk biomarkers: a randomized, placebo-controlled, crossover trial in men at moderate risk of cardiovascular disease. Am J Clin Nutr. 2015 May;101(5):931-8. doi: 10.3945/ajcn.114.104364. Epub 2015 Mar 18.
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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.
Aedin Cassidy, PhD principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavanone - supplement, Flavanone - food and Isoflavone - supplement in people with Cardiovascular Disease Risk Reduction, run by University of East Anglia 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 5 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 28 Feb 2014. 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?
Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration. (time frame: acute postprandial; up to 24 hours, dependent on flavonoid sub-classification studied). 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 NCT01530893, which also lists 2 linked publications.
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 28 Feb 2014.