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Impact of isoQUercetin and Aspirin on Platelet Function

NCT ID: NCT02866448

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Cardiovascular Disease

Keywords

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Cardiovascular disease Flavonoid Isoquercetin Aspirin Platelet function Vascular function Blood pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Vehicle control

Intervention Type DRUG

Described in arm

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

Group Type EXPERIMENTAL

Isoquercetin

Intervention Type DRUG

Described in arm

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

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Described in arm

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

Group Type EXPERIMENTAL

Isoquercetin plus Aspirin

Intervention Type DRUG

Described in arm

Interventions

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Vehicle control

Described in arm

Intervention Type DRUG

Isoquercetin

Described in arm

Intervention Type DRUG

Aspirin

Described in arm

Intervention Type DRUG

Isoquercetin plus Aspirin

Described in arm

Intervention Type DRUG

Other Intervention Names

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Vehicle IsoQ, IsoQblend ASA IsoQ + ASA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biotechnology and Biological Sciences Research Council

OTHER

Sponsor Role collaborator

Quercegen Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Julie Lovegrove

Head of Hugh Sinclair Unit of Human Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie A Lovegrove, BSc PhD RNutr

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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University of Reading

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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16/38

Identifier Type: -

Identifier Source: org_study_id