An interventional study of Polyphenol extract and Placebo in Cardiovascular Diseases, Endothelial Dysfunction and Blood Pressure, sponsored by University of Ulster. Status unknown at 1 site in United Kingdom. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by University of Ulster · Not applicable, Interventional, and Prevention
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
156mg single dose
Dietary Supplement: Polyphenol extract
222mg single dose
Dietary Supplement: Polyphenol extract
333mg single dose
Dietary Supplement: Polyphenol extract
Maltodextrin single dose
Dietary Supplement: Placebo
Single dose
Maltodextrin
Flow Mediated Dilation
Acute change in endothelium-dependent flow-mediated dilation
Time frame: Change over 2 hours post dose
Endothelium-independent vasodilation
Acute change in endothelium-independent vasodilation in response to Glyceryl trinitrate (GTN) drug
Time frame: Change after 2 hours post dose
Systolic blood pressure
Measured by brachial cuff
Time frame: Change over 2 hours post dose
Diastolic blood pressure
Measured by brachial cuff
Time frame: Change over 2 hours post dose
Lipid profile
Measured in serum
Time frame: Visit 1, 0 hour only
Glucose
Measured in plasma
Time frame: Visit 1, 0 hour only
Tolerance and acceptability of extract
Safety parameter. Measured on a 3-point likert scale (a lower value being a better outcome: 1, totally acceptable - 3, not at all acceptable)
Time frame: Immediately after each intervention
Height
Measured in metres
Time frame: Visit 1, 0 hour only
Weight
Measured in kg
Time frame: 0 hour, at each time-point
Angiotensin-converting enzyme (ACE)
Exploratory outcome
Time frame: Change over 2 hours
Circulating polyphenol metabolites
Exploratory outcome. Measured in plasma
Time frame: Change over 2 hours
Endothelin1
Exploratory outcome. Measured in serum
Time frame: Change over 2 hours
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of Ulster