Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study

Not Applicable

• Conditions: Blood Pressure; Cardiovascular Diseases; Endothelial Dysfunction

• Registration Number: NCT05220059
• Lead Sponsor: University of Ulster

Brief Summary

Endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. It is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Finding dietary/dietary supplement-oriented approaches to improving endothelial function is of public health interest.

A randomized double-blind placebo controlled 4-way crossover study will be conducted to determine if acute consumption of a proprietary polyphenol extract (156 mg / 222 mg / 333 mg) will have a dose dependent response on endothelium-dependent flow-mediated dilation (ED-FMD) in fasting conditions, in comparison to a placebo (maltodextrin) in male smokers (20 - 45 years; n=20).FMD and blood pressure will be assessed at 0 \& 2 hour timepoints following consumption of a single dose of polyphenol extract, accompanying blood samples will be collected to assess a range of endpoints including nitric oxide metabolites, angiotensin and polyphenols metabolites. Endothelium-independent vasodilation will also be measured 2 hours post consumption.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-26
• Study Start: 2021-12-01
• Primary Completion: 2021-12-01
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-11
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• At least two of the following risk markers; a BMI 25-30, waist circumference >94 cm, high normal blood pressure defined as either systolic 85-89 mmHg or diastolic 130-139 mmHg and have a normal ECG.

Exclusion Criteria

• An individual who has tested positive (self reported) 2 weeks before the study period.
• A COVID-19 vaccinated individual who while receive the 1st or 2nd dose or booster 2 weeks before V0 or during the study period, due to the potential interaction of vaccine on markers assessed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Flow Mediated Dilation	Change over 2 hours post dose	Acute change in endothelium-dependent flow-mediated dilation

Secondary Outcome Measures

Name	Time	Method
Diastolic blood pressure	Change over 2 hours post dose	Measured by brachial cuff
Endothelium-independent vasodilation	Change after 2 hours post dose	Acute change in endothelium-independent vasodilation in response to Glyceryl trinitrate (GTN) drug
Systolic blood pressure	Change over 2 hours post dose	Measured by brachial cuff

Trial Locations

Locations (1)

Human Intervention Studies Unit, Ulster University; 🇬🇧 Coleraine, Co.Londonderry, United Kingdom