Impact of isoQUercetin and Aspirin on Platelet Function

Overview

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.

Full Title of Study: “The Impact of Isoquercetin and Aspirin on Platelet Function”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2016

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)).

Interventions

  • Drug: Vehicle control
    • Described in arm
  • Drug: Isoquercetin
    • Described in arm
  • Drug: Aspirin
    • Described in arm
  • Drug: Isoquercetin plus Aspirin
    • Described in arm

Arms, Groups and Cohorts

  • 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
  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in platelet aggregation
    • Time Frame: Acute Study: measured at -60 (baseline), 120, 240 and 360min

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Reading
  • Collaborator
    • Biotechnology and Biological Sciences Research Council
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie Lovegrove, Head of Hugh Sinclair Unit of Human Nutrition – University of Reading
  • Overall Official(s)
    • Julie A Lovegrove, BSc PhD RNutr, Principal Investigator, University of Reading

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