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

NCT05220059 | Unknown

• 1 other identifier: REC/21/0029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Endothelial Dysfunction; Blood Pressure

Keywords

Polyphenols; Cardiovascular Disease; Endothelial Function; Flow Mediated Dilation

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilation

  Acute change in endothelium-dependent flow-mediated dilation

  Change over 2 hours post dose

Secondary Outcomes (3)

• Endothelium-independent vasodilation

  Change after 2 hours post dose

• Systolic blood pressure

  Change over 2 hours post dose

• Diastolic blood pressure

  Change over 2 hours post dose

Other Outcomes (8)

• Lipid profile

  Visit 1, 0 hour only

• Glucose

  Visit 1, 0 hour only

• Tolerance and acceptability of extract

  Immediately after each intervention

Study Arms (4)

Polyphenol extract low dose

EXPERIMENTAL

156mg single dose

Dietary Supplement: Polyphenol extract

Polyphenol extract medium dose

EXPERIMENTAL

222mg single dose

Dietary Supplement: Polyphenol extract

Polyphenol extract high dose

EXPERIMENTAL

333mg single dose

Dietary Supplement: Polyphenol extract

Placebo

PLACEBO COMPARATOR

Maltodextrin single dose

Dietary Supplement: Placebo

Interventions

Polyphenol extract DIETARY_SUPPLEMENT

Single dose

Polyphenol extract high dose; Polyphenol extract low dose; Polyphenol extract medium dose

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Polyphenols have a gender effect, a single sex population was chosen to increase homogeneity of test population and therefore likelihood of observing an FMD response. Males were selected.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead
• University of Parma: collaborator
• Activ'inside: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Polyphenols

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Christopher Gill

CONTACT

+442870123181; c.gill@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind placebo controlled dose-response crossover study

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: February 2, 2022
• Study Start: December 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 30, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)