Impact of isoQUercetin and Aspirin on Platelet Function (QUAP)

November 28, 2016 updated by: Julie Lovegrove, University of Reading

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AP
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Vehicle control

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
Drug: Vehicle control
Described in arm
Other Names:
  • Vehicle
Experimental: Isoquercetin

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
Drug: Isoquercetin
Described in arm
Other Names:
  • IsoQ, IsoQblend
Active Comparator: Aspirin

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
Drug: Aspirin
Described in arm
Other Names:
  • ASA
Experimental: Isoquercetin plus Aspirin

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
Drug: Isoquercetin plus Aspirin
Described in arm
Other Names:
  • IsoQ + ASA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in platelet aggregation
Time Frame: Acute Study: measured at -60 (baseline), 120, 240 and 360min
Acute Study: measured at -60 (baseline), 120, 240 and 360min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
Acute study: measured at 0 (baseline),120, 240 and 360min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Reading

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biotechnology and Biological Sciences Research Council
Quercegen Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16/38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be averaged (some will also be normalized) before publishing, IPD (Individual Participant Data) will not be made available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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