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

Cardiovascular Diseases Clinical Trial

— Activ Acute  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220059
• Other study ID #: REC/21/0029
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2022
• Source: University of Ulster
• Contact: Christopher Gill
• Phone: +442870123181
• Email: c.gill[@]ulster.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Endothelial Dysfunction

Intervention

Dietary Supplement:
• Polyphenol extract
Single dose
• Placebo
Maltodextrin

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit, Ulster University	Coleraine	Co.Londonderry

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulster	Activ'inside, University of Parma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipid profile	Measured in serum	Visit 1, 0 hour only
Other	Glucose	Measured in plasma	Visit 1, 0 hour only
Other	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)	Immediately after each intervention
Other	Height	Measured in metres	Visit 1, 0 hour only
Other	Weight	Measured in kg	0 hour, at each time-point
Other	Angiotensin-converting enzyme (ACE)	Exploratory outcome	Change over 2 hours
Other	Circulating polyphenol metabolites	Exploratory outcome. Measured in plasma	Change over 2 hours
Other	Endothelin1	Exploratory outcome. Measured in serum	Change over 2 hours
Primary	Flow Mediated Dilation	Acute change in endothelium-dependent flow-mediated dilation	Change over 2 hours post dose
Secondary	Endothelium-independent vasodilation	Acute change in endothelium-independent vasodilation in response to Glyceryl trinitrate (GTN) drug	Change after 2 hours post dose
Secondary	Systolic blood pressure	Measured by brachial cuff	Change over 2 hours post dose
Secondary	Diastolic blood pressure	Measured by brachial cuff	Change over 2 hours post dose