Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study (Activ Acute)

Ulster University

Status: Unknown

Conditions: Endothelial Dysfunction; Cardiovascular Diseases; Blood Pressure

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Polyphenol extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05220059

REC/21/0029

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 4 patient groups, including a placebo group

Polyphenol extract low dose

Experimental group

Description:

156mg single dose

Treatment:

Dietary Supplement: Polyphenol extract

Polyphenol extract medium dose

Experimental group

Description:

222mg single dose

Treatment:

Dietary Supplement: Polyphenol extract

Polyphenol extract high dose

Experimental group

Description:

333mg single dose

Treatment:

Dietary Supplement: Polyphenol extract

Placebo

Placebo Comparator group

Description:

Maltodextrin single dose

Treatment:

Dietary Supplement: Placebo