Cardiovascular DiseaseQUAPNCT02866448
Impact of isoQUercetin and Aspirin on Platelet Function
A study testing Isoquercetin, Aspirin and Isoquercetin plus Aspirin in people with Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effect of acute isoquercetin supplementation, aspirin, and isoquercetin/aspirin combination on platelet aggregation, blood pressure and vasculat stiffness (eg digital volume pulse), as well as investigating the plasma accumulation and urine excretion profiles of… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Isoquercetin, Aspirin and Isoquercetin plus Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Plasma TAG (triacylglycerol) < 4.0 mmol/l
- Body mass index (BMI) between 18-35 kg/m2
- Total cholesterol (TC): <7 mmol/l
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
- Consume less than 5 portions of fruit/vegetables per day
- Male
Who cannot join
- Suffered a myocardial infarction/stroke in the past 12 months
- Diabetic (diagnosed as fasting blood glucose >7 mmol/l) or suffer from other endocrine disorders
- Suffering from renal or bowel disease or have a history of cholestatic liver or pancreatitis
- On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- History of alcohol abuse
- Planning or on a weight reducing regime
Show all 23Show fewer
- Undertake vigorous exercise more than 3 times a week
- Taking nutritional supplements (e.g. fish oil, calcium)
- Taking flavonoid supplements
- Suffering from hayfever
- Taking any, or intolerant to, NSAIDS including aspirin
- On any medication, prescribed or not prescribed (or willing to abstain from these during period of study as well as prior 2 week washout period)
- Using any recreational drugs
- Vegan
- Intolerant/allergic to nuts, wheat, dairy
- Intolerant/allergic to aspirin
- On, or have taken antibiotics in the last 2 months
- Had surgery in the last 3 months
- Smokers, or have smoked in the last month
- Using e-cigarettes
- Anaemic: haemoglobin <12.5 g/dl
- History of gastric ulcers
- Female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Isoquercetin and Aspirin on Platelet Function
The purpose of this study is to investigate the effect of acute isoquercetin supplementation, aspirin, and isoquercetin/aspirin combination on platelet aggregation, blood pressure and vasculat stiffness (eg digital volume pulse), as well as investigating the plasma accumulation and urine excretion profiles of quercetin.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death worldwide. In 2012, approximately 17.5 million people worldwide died from CVD, representing 31% of global death. Flavonoids are a class of plant secondary metabolites, functioning in the plant to aid in growth. These compounds are found in diets worldwide, and many cohort studies have demonstrated the protective effect of diets high in flavonoids against CVD events, with some studies showing flavonoid intake inversely associated with CV event risk, CV non-fatal events and all-cause mortality. One consistent issue with quercetin as a dietary flavonoid is the plasma concentrations it is able to reach are not always sufficient to provide a protective effect. Therefore, supplementation or pharmacological intervention with flavonoids may offer a solution. Supplementation with isoquercetin, the 3-O-glucoside of quercetin, offers the potential for much higher plasma concentrations of quercetin and its metabolites than dietary sources can offer, with associated increased inhibitory, anti-platelet effects. It must therefore be addressed whether isoquercetin supplementation can effectively reduce platelet function ex vivo, measured by aggregation and closure time, as well as improve vascular function, measured through blood pressure (BP) and vascular stiffness (eg digital volume pulse (DVP)).
- Conditions
- Cardiovascular Disease
- Being tested
- Vehicle control, Isoquercetin, Aspirin, Isoquercetin plus Aspirin
- Keywords
- Cardiovascular disease, Flavonoid, Isoquercetin, Aspirin, Platelet function, Vascular function, Blood pressure
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle controlDrug
Also called Vehicle
Described in arm
IsoquercetinDrug
Also called IsoQ, IsoQblend
Described in arm
AspirinDrug
Also called ASA
Described in arm
Isoquercetin plus AspirinDrug
Also called IsoQ + ASA
Described in arm
| Study group | Role | What they receive |
|---|---|---|
| Vehicle control | Placebo comparator | Subjects will consume
* 4 x 250mg cellulose capsules containing 250mg cellulose, 62mg Ascorbic acid (Vitamin C), 5mg Nicotinic acid (Vitamin B3) and 0.25mg Folic Acid
* 1 x 75mg cellulose pill Receives: Drug: Vehicle control |
| Isoquercetin | Experimental | Subjects will consume
* 4 x 250mg isoquercetin capsules containing 250mg isoquercetin, 62mg Ascorbic acid (Vitamin C), 5mg Nicotinic acid (Vitamin B3) and 0.25mg Folic Acid
* 1 x 75mg cellulose pill Receives: Drug: Isoquercetin |
| Aspirin | Active comparator | Subjects will consume
* 1 x 75mg dispersible aspirin
* 4 x 250mg cellulose capsules containing 250mg cellulose, 62mg Ascorbic acid (Vitamin C), 5mg Nicotinic acid (Vitamin B3) and 0.25mg Folic Acid Receives: Drug: Aspirin |
| Isoquercetin plus Aspirin | Experimental | Subjects will consume
* 4 x 250mg isoquercetin capsules containing 250mg isoquercetin, 62mg Ascorbic acid (Vitamin C), 5mg Nicotinic acid (Vitamin B3) and 0.25mg folic acid
* 1 x 75mg dispersible aspirin Receives: Drug: Isoquercetin plus Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in platelet aggregation
Measured: Acute Study: measured at -60 (baseline), 120, 240 and 360min
Secondary outcomes (6)
Change from baseline in Closure Time (CT), measured with a Platelet Function Analyzer (PFA)
Measured: Acute study: measured at -60 (baseline), 120, 240 and 360min
Change from baseline in blood pressure (systolic pressure, diastolic pressure and pulse pressure)
Measured: Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min
Change from baseline in arterial stiffness measured by digital volume pulse - stiffness index
Measured: Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min
Change from baseline in arterial stiffness measured by digital volume pulse - reflection index
Measured: Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min
Change from baseline in total plasma quercetin concentration (micromolar)
Measured: Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min
Change from baseline in total urine quercetin concentration (micromolar)
Measured: Acute study: measured at 0 (baseline),120, 240 and 360min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Funding delayed beyond acceptable start date
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Quercegen Pharmaceuticals
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A Lovegrove, BSc PhD RNutr, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866448
- Sponsor's protocol ID
- 16/38
- Acronym
- QUAP
- Status last verified
- Nov 2016
- First submitted
- 2 Aug 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be averaged (some will also be normalized) before publishing, IPD (Individual Participant Data) will not be made available
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Isoquercetin and Aspirin on Platelet Function
- ClinicalTrials.gov ID
- NCT02866448
- Acronym / sponsor ID
- QUAP / 16/38
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Flavonoid, Isoquercetin, Aspirin, Platelet function, Vascular function, Blood pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding delayed beyond acceptable start date
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Quercegen Pharmaceuticals
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Aug 2016 (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 purpose of this study is to investigate the effect of acute isoquercetin supplementation, aspirin, and isoquercetin/aspirin combination on platelet aggregation, blood pressure and vasculat stiffness (eg digital volume pulse), as well as investigating the plasma accumulation and urine excretion profiles of quercetin.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death worldwide. In 2012, approximately 17.5 million people worldwide died from CVD, representing 31% of global death. Flavonoids are a class of plant secondary metabolites, functioning in the plant to aid in growth. These compounds are found in diets worldwide, and many cohort studies have demonstrated the protective effect of diets high in flavonoids against CVD events, with some studies showing flavonoid intake inversely associated with CV event risk, CV non-fatal events and all-cause mortality. One consistent issue with quercetin as a dietary flavonoid is the plasma concentrations it is able to reach are not always sufficient to provide a protective effect. Therefore, supplementation or pharmacological intervention with flavonoids may offer a solution. Supplementation with isoquercetin, the 3-O-glucoside of quercetin, offers the potential for much higher plasma concentrations of quercetin and its metabolites than dietary sources can offer, with associated increased inhibitory, anti-platelet effects. It must therefore be addressed whether isoquercetin supplementation can effectively reduce platelet function ex vivo, measured by aggregation and closure time, as well as improve vascular function, measured through blood pressure (BP) and vascular stiffness (eg digital volume pulse (DVP)).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vehicle control | Placebo comparator | Drug: Vehicle controlSubjects will consume * 4 x 250mg cellulose capsules containing 250mg cellulose, 62mg Ascorbic acid (Vitamin C), 5mg Nicotinic acid (Vitamin B3) and 0.25mg Folic Acid * 1 x 75mg cellulose pill |
| Isoquercetin | Experimental | Drug: IsoquercetinSubjects will consume * 4 x 250mg isoquercetin capsules containing 250mg isoquercetin, 62mg Ascorbic acid (Vitamin C), 5mg Nicotinic acid (Vitamin B3) and 0.25mg Folic Acid * 1 x 75mg cellulose pill |
| Aspirin | Active comparator | Drug: AspirinSubjects will consume * 1 x 75mg dispersible aspirin * 4 x 250mg cellulose capsules containing 250mg cellulose, 62mg Ascorbic acid (Vitamin C), 5mg Nicotinic acid (Vitamin B3) and 0.25mg Folic Acid |
| Isoquercetin plus Aspirin | Experimental | Drug: Isoquercetin plus AspirinSubjects will consume * 4 x 250mg isoquercetin capsules containing 250mg isoquercetin, 62mg Ascorbic acid (Vitamin C), 5mg Nicotinic acid (Vitamin B3) and 0.25mg folic acid * 1 x 75mg dispersible aspirin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Plasma TAG (triacylglycerol) < 4.0 mmol/l
- Body mass index (BMI) between 18-35 kg/m2
- Total cholesterol (TC): <7 mmol/l
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
- Consume less than 5 portions of fruit/vegetables per day
Key exclusion criteria (23 listed)
- Suffered a myocardial infarction/stroke in the past 12 months
- Diabetic (diagnosed as fasting blood glucose >7 mmol/l) or suffer from other endocrine disorders
- Suffering from renal or bowel disease or have a history of cholestatic liver or pancreatitis
- On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- History of alcohol abuse
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 |
|---|---|---|
| Vehicle controlAlso: VehicleDescribed in arm | Drug | Vehicle control |
| IsoquercetinAlso: IsoQ, IsoQblendDescribed in arm | Drug | Isoquercetin |
| AspirinAlso: ASADescribed in arm | Drug | Aspirin |
| Isoquercetin plus AspirinAlso: IsoQ + ASADescribed in arm | Drug | Isoquercetin plus Aspirin |
Primary outcome
Change from baseline in platelet aggregation
Time frame: Acute Study: measured at -60 (baseline), 120, 240 and 360min
6 secondary outcomes
Change from baseline in Closure Time (CT), measured with a Platelet Function Analyzer (PFA)
Time frame: Acute study: measured at -60 (baseline), 120, 240 and 360min
Change from baseline in blood pressure (systolic pressure, diastolic pressure and pulse pressure)
Time frame: Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min
Change from baseline in arterial stiffness measured by digital volume pulse - stiffness index
Time frame: Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min
Change from baseline in arterial stiffness measured by digital volume pulse - reflection index
Time frame: Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min
Change from baseline in total plasma quercetin concentration (micromolar)
Time frame: Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min
Change from baseline in total urine quercetin concentration (micromolar)
Time frame: Acute study: measured at 0 (baseline),120, 240 and 360min
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: No. Data will be averaged (some will also be normalized) before publishing, IPD (Individual Participant Data) will not be made available
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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.
Julie A Lovegrove, BSc PhD RNutr principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoquercetin, Aspirin and Isoquercetin plus Aspirin in people with Cardiovascular Disease, run by University of Reading 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 6 inclusion and 23 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: withdrawn, as of the sponsor's last update on 29 Nov 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 was withdrawn before enrolling participants, so there are no results.
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 platelet aggregation (time frame: Acute Study: measured at -60 (baseline), 120, 240 and 360min). 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 29 Nov 2016.