Impact of isoQUercetin and Aspirin on Platelet Function

NCT02866448 | Withdrawn

• 1 other identifier: 16/38
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; Flavonoid; Isoquercetin; Aspirin; Platelet function; Vascular function; Blood pressure

Outcome Measures

Primary Outcomes (1)

• Change from baseline in platelet aggregation

  Acute Study: measured at -60 (baseline), 120, 240 and 360min

Secondary Outcomes (6)

• Change from baseline in Closure Time (CT), measured with a Platelet Function Analyzer (PFA)

  Acute study: measured at -60 (baseline), 120, 240 and 360min

• 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

• 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

• 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

• 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

Study Arms (4)

Vehicle control

PLACEBO COMPARATOR

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

Isoquercetin

EXPERIMENTAL

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

Aspirin

ACTIVE COMPARATOR

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

Isoquercetin plus Aspirin

EXPERIMENTAL

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

Interventions

Vehicle control DRUG

Described in arm

Also known as: Vehicle

Vehicle control

Isoquercetin DRUG

Described in arm

Also known as: IsoQ, IsoQblend

Isoquercetin

Aspirin DRUG

Described in arm

Also known as: ASA

Aspirin

Isoquercetin plus Aspirin DRUG

Described in arm

Also known as: IsoQ + ASA

Isoquercetin plus Aspirin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Biotechnology and Biological Sciences Research Council: collaborator
• Quercegen Pharmaceuticals: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

isoquercitrin; Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Julie A Lovegrove, BSc PhD RNutr

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hugh Sinclair Unit of Human Nutrition

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 15, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)