Blood PressureFLAVASCULARNCT02013856
The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk (FLAVASCULAR Study)
A study testing Low Epicatechin and procyanidin, High Epicatechin and procyanidin and High procyanidin in people with Blood Pressure, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (CVD). The protective effect may be ascribed to compounds contained within these foods, called flavonoids. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Low Epicatechin and procyanidin, High Epicatechin and procyanidin and High procyanidin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Oct 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ≥ 50 years of age
- Systolic blood pressure 130 - 159 mmHg
Who cannot join
- History of cardiovascular events such as stroke, myocardial infarction trans- ischaemic attacks or peripheral vascular disease
- Kidney or liver disease/problems
- Diabetes
- Asthmatics (unless no medication taken for 1 year - occasional use will be assessed on an individual basis)
- Prescribed anti-hypertensive medication
- HRT (unless the participant has used the therapy for ≥ 6 months)
Show all 17Show fewer
- Lipid lowering therapies e.g. statins
- Other medications that may affect any of the study outcome measures e.g. vasodilators (this will be assessed on a case by case basis)
- Current smoker (or stopped for less than 3 months)
- Throat surgery or neck injury
- Allergy to apples
- Consumption of fish oil supplements unless willing to discontinue them up for 4 weeks preceding the start of the study and for the duration of the study. (All other supplements will be assessed on a case by case basis)
- Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
- 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 ml.
- 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 (mmHg)) during the course of the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UA
About this study
Official title: The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk
Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (CVD). The protective effect may be ascribed to compounds contained within these foods, called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine. There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the acute and chronic effects of apple derived flavanols on some risk markers for CVD.
Read the detailed description
This study is a single arm randomized, 4-phase crossover design.
- Conditions
- Blood Pressure
- Being tested
- Low Epicatechin and procyanidin, High Epicatechin and procyanidin, High procyanidin, Placebo
- Keywords
- Blood pressure, Flavanols, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Epicatechin and procyanidinDietary supplement
70 mg epicatechin and 65 mg procyanidins once daily for 28 days
High Epicatechin and procyanidinDietary supplement
140 mg epicatechin and 130 mg procyanidins once daily for 28 days
High procyanidinDietary supplement
No epicatechin and 130 mg procyanidins once daily for 28 days
PlaceboDietary supplement
Placebo control once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Low Epicatechin and procyanidin | Experimental | Low epicatechin and procyanidin doses Receives: Dietary Supplement: Low Epicatechin and procyanidin |
| High Epicatechin and procyanidin | Experimental | High epicatechin and procyanidin doses Receives: Dietary Supplement: High Epicatechin and procyanidin |
| High Procyanidin | Experimental | High procyanidin only Receives: Dietary Supplement: High procyanidin |
| Placebo | Placebo comparator | No epicatechin and procyanidin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systolic blood pressure from baseline
Measured: Baseline, 2 hours and 4 weeks
Secondary outcomes (5)
Changes in plasma lipid profile from baseline
Measured: Baseline and 4 weeks
Change in plasma endothelin-1 from baseline
Measured: Baseline and 4 weeks
Changes in plasma nitric oxide metabolites from baseline
Measured: Baseline, 2 hours and 4 weeks
Changes in blood glucose from baseline
Measured: Baseline and 4 weeks
Changes in pulse wave velocity from baseline
Measured: Baseline, 2 hours and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJul 2014
- Primary completionOct 2016
- Study completionOct 2016
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 Blood PressureStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Dr Kroon, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013856
- Sponsor's protocol ID
- IFR05/2013
- Acronym
- FLAVASCULAR
- Status last verified
- Nov 2015
- First submitted
- 9 Dec 2013
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hollands WJ, Tapp H, Defernez M, Perez Moral N, Winterbone MS, Philo M, Lucey AJ, Kiely ME, Kroon PA. Lack of acute or chronic effects of epicatechin-rich and procyanidin-rich apple extracts on blood pressure and cardiometabolic biomarkers in adults with moderately elevated blood pressure: a randomized, placebo-controlled crossover trial. Am J Clin Nutr. 2018 Nov 1;108(5):1006-1014. doi: 10.1093/ajcn/nqy139.
PubMed 30475960
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT02013856
- Acronym / sponsor ID
- FLAVASCULAR / IFR05/2013
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, Flavanols, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Dec 2013 (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.
Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (CVD). The protective effect may be ascribed to compounds contained within these foods, called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine. There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the acute and chronic effects of apple derived flavanols on some risk markers for CVD.
Detailed description
This study is a single arm randomized, 4-phase crossover design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Epicatechin and procyanidin | Experimental | Dietary Supplement: Low Epicatechin and procyanidinLow epicatechin and procyanidin doses |
| High Epicatechin and procyanidin | Experimental | Dietary Supplement: High Epicatechin and procyanidinHigh epicatechin and procyanidin doses |
| High Procyanidin | Experimental | Dietary Supplement: High procyanidinHigh procyanidin only |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNo epicatechin and procyanidin |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women ≥ 50 years of age
- Systolic blood pressure 130 - 159 mmHg
Key exclusion criteria (17 listed)
- History of cardiovascular events such as stroke, myocardial infarction trans- ischaemic attacks or peripheral vascular disease
- Kidney or liver disease/problems
- Diabetes
- Asthmatics (unless no medication taken for 1 year - occasional use will be assessed on an individual basis)
- Prescribed anti-hypertensive medication
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 |
|---|---|---|
| Low Epicatechin and procyanidin70 mg epicatechin and 65 mg procyanidins once daily for 28 days | Dietary supplement | Low Epicatechin and procyanidin |
| High Epicatechin and procyanidin140 mg epicatechin and 130 mg procyanidins once daily for 28 days | Dietary supplement | High Epicatechin and procyanidin |
| High procyanidinNo epicatechin and 130 mg procyanidins once daily for 28 days | Dietary supplement | High Procyanidin |
| PlaceboPlacebo control once daily for 28 days | Dietary supplement | Placebo |
Primary outcome
Changes in systolic blood pressure from baseline
Time frame: Baseline, 2 hours and 4 weeks
5 secondary outcomes
Changes in plasma lipid profile from baseline
Time frame: Baseline and 4 weeks
Change in plasma endothelin-1 from baseline
Time frame: Baseline and 4 weeks
Changes in plasma nitric oxide metabolites from baseline
Time frame: Baseline, 2 hours and 4 weeks
Changes in blood glucose from baseline
Time frame: Baseline and 4 weeks
Changes in pulse wave velocity from baseline
Time frame: Baseline, 2 hours and 4 weeks
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 2 Dec 2016.
- Derived from this study: PubMed 30475960Hollands WJ, Tapp H, Defernez M, Perez Moral N, Winterbone MS, Philo M, Lucey AJ, Kiely ME, Kroon PA. Lack of acute or chronic effects of epicatechin-rich and procyanidin-rich apple extracts on blood pressure and cardiometabolic biomarkers in adults with moderately elevated blood pressure: a randomized, placebo-controlled crossover trial. Am J Clin Nutr. 2018 Nov 1;108(5):1006-1014. doi: 10.1093/ajcn/nqy139.
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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 Dr 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 Low Epicatechin and procyanidin, High Epicatechin and procyanidin and High procyanidin in people with Blood Pressure, 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 2 inclusion and 17 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 2 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
Changes in systolic blood pressure from baseline (time frame: Baseline, 2 hours and 4 weeks). 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 NCT02013856, 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 2 Dec 2016.