Clinical trial NCT05220059: Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study
Official title: Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Endothelial Dysfunction
Blood Pressure
Keywords: Polyphenols
Cardiovascular Disease
Endothelial Function
Flow Mediated Dilation
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: University of Parma
name: Activ'inside
First posted: 2022-02-02
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind placebo controlled dose-response crossover study
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Flow Mediated Dilation
timeFrame: Change over 2 hours post dose
Secondary outcomes:
measure: Endothelium-independent vasodilation
timeFrame: Change after 2 hours post dose
measure: Systolic blood pressure
timeFrame: Change over 2 hours post dose
measure: Diastolic blood pressure
timeFrame: Change over 2 hours post dose
Other outcomes:
measure: Lipid profile
timeFrame: Visit 1, 0 hour only
measure: Glucose
timeFrame: Visit 1, 0 hour only
measure: Tolerance and acceptability of extract
timeFrame: Immediately after each intervention
measure: Height
timeFrame: Visit 1, 0 hour only
measure: Weight
timeFrame: 0 hour, at each time-point
measure: Angiotensin-converting enzyme (ACE)
timeFrame: Change over 2 hours
measure: Circulating polyphenol metabolites
timeFrame: Change over 2 hours
measure: Endothelin1
timeFrame: Change over 2 hours
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University
state: Co.Londonderry
Study officials:
References: