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Clinical Trials/NCT05220059
NCT05220059
Unknown
Not Applicable

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

University of Ulster1 site in 1 country20 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
University of Ulster
Enrollment
20
Locations
1
Primary Endpoint
Flow Mediated Dilation
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Flow Mediated Dilation

Time Frame: Change over 2 hours post dose

Acute change in endothelium-dependent flow-mediated dilation

Secondary Outcomes

  • Diastolic blood pressure(Change over 2 hours post dose)
  • Endothelium-independent vasodilation(Change after 2 hours post dose)
  • Systolic blood pressure(Change over 2 hours post dose)

Study Sites (1)

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