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Trial record 6 of 1254 for:    ASPIRIN AND Platelet Aggregation

Impact of isoQUercetin and Aspirin on Platelet Function (QUAP)

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ClinicalTrials.gov Identifier: NCT02866448
Recruitment Status : Withdrawn (Funding delayed beyond acceptable start date)
First Posted : August 15, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborators:
Biotechnology and Biological Sciences Research Council
Quercegen Pharmaceuticals
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

Brief 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 quercetin.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Vehicle control Drug: Isoquercetin Drug: Aspirin Drug: Isoquercetin plus Aspirin Not Applicable

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)).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Isoquercetin and Aspirin on Platelet Function
Study Start Date : August 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: IsoQ + ASA




Primary Outcome Measures :
  1. Change from baseline in platelet aggregation [ Time Frame: Acute Study: measured at -60 (baseline), 120, 240 and 360min ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Change from baseline in total urine quercetin concentration (micromolar) [ Time Frame: Acute study: measured at 0 (baseline),120, 240 and 360min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866448


Locations
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United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Biotechnology and Biological Sciences Research Council
Quercegen Pharmaceuticals
Investigators
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Principal Investigator: Julie A Lovegrove, BSc PhD RNutr University of Reading

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Responsible Party: Julie Lovegrove, Head of Hugh Sinclair Unit of Human Nutrition, University of Reading
ClinicalTrials.gov Identifier: NCT02866448     History of Changes
Other Study ID Numbers: 16/38
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be averaged (some will also be normalized) before publishing, IPD (Individual Participant Data) will not be made available

Keywords provided by Julie Lovegrove, University of Reading:
Cardiovascular disease
Flavonoid
Isoquercetin
Aspirin
Platelet function
Vascular function
Blood pressure

Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics