NCT05220059

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Ulster · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Diseases
• Endothelial Dysfunction
• Blood Pressure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polyphenol extract	Single dose
DIETARY_SUPPLEMENT	Placebo	Maltodextrin

Timeline

• Start date: 2021-12-01
• Primary completion: 2021-12-01
• Completion: 2022-06-30
• First posted: 2022-02-02
• Last updated: 2022-03-11

Locations

1 site across 1 country: United Kingdom