Impact of isoQUercetin and Aspirin on Platelet Function

Cardiovascular Disease Clinical Trial

— QUAP  

Official title:

The Impact of Isoquercetin and Aspirin on Platelet Function

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02866448
• Other study ID #: 16/38
• Status: Withdrawn
• Phase: N/A
• First received: August 2, 2016
• Last updated: November 28, 2016
• Start date: August 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical 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 quercetin.

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)).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Reading	Biotechnology and Biological Sciences Research Council, Quercegen Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in platelet aggregation		Acute Study: measured at -60 (baseline), 120, 240 and 360min	No
Secondary	Change from baseline in Closure Time (CT), measured with a Platelet Function Analyzer (PFA)		Acute study: measured at -60 (baseline), 120, 240 and 360min	No
Secondary	Change from baseline in blood pressure (systolic pressure, diastolic pressure and pulse pressure)		Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min	No
Secondary	Change from baseline in arterial stiffness measured by digital volume pulse - stiffness index		Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min	No
Secondary	Change from baseline in arterial stiffness measured by digital volume pulse - reflection index		Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min	No
Secondary	Change from baseline in total plasma quercetin concentration (micromolar)		Acute study: measured at -60 (baseline), 0, 30, 60, 90, 120, 180, 240, 300 and 360min	No
Secondary	Change from baseline in total urine quercetin concentration (micromolar)		Acute study: measured at 0 (baseline),120, 240 and 360min	No