Blood Pressure, Cardiovascular Diseases, Endothelial Dysfunction
Conditions
Keywords
Polyphenols, Cardiovascular Disease, Endothelial Function, Flow Mediated Dilation
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.
Interventions
DIETARY_SUPPLEMENTPolyphenol extract
Single dose
DIETARY_SUPPLEMENTPlacebo
Maltodextrin
Sponsors
University of Parma
Activ'inside
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-blinded
Intervention model description
Double-blind placebo controlled dose-response crossover study
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation | Change over 2 hours post dose | Acute change in endothelium-dependent flow-mediated dilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Diastolic blood pressure | Change over 2 hours post dose | Measured by brachial cuff |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight | 0 hour, at each time-point | Measured in kg |
| Angiotensin-converting enzyme (ACE) | Change over 2 hours | Exploratory outcome |
| Lipid profile | Visit 1, 0 hour only | Measured in serum |
| Endothelin1 | Change over 2 hours | Exploratory outcome. Measured in serum |
| Circulating polyphenol metabolites | Change over 2 hours | Exploratory outcome. Measured in plasma |
| Glucose | Visit 1, 0 hour only | Measured in plasma |
| Tolerance and acceptability of extract | Immediately after each intervention | Safety parameter. Measured on a 3-point likert scale (a lower value being a better outcome: 1, totally acceptable - 3, not at all acceptable) |
| Height | Visit 1, 0 hour only | Measured in metres |
Countries
United Kingdom
Contacts
Primary ContactChristopher Gill
Outcome results
None listed