Cardiovascular DiseasesActiv AcuteNCT05220059
Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study
A study testing Polyphenol extract in people with Cardiovascular Diseases and Endothelial Dysfunction, run by University of Ulster at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Endothelial Dysfunction, Blood Pressure
- What is being tested?
- Polyphenol extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
Ruth K Price, +442870123878, rk.price@ulster.ac.uk
Julie J Sittlington, +442870124101, jj.sittlington@ulster.ac.uk
About this study
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.
- Being tested
- Polyphenol extract, Placebo
- Keywords
- Polyphenols, Cardiovascular Disease, Endothelial Function, Flow Mediated Dilation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol extractDietary supplement
Single dose
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Polyphenol extract low dose | Experimental | 156mg single dose Receives: Dietary Supplement: Polyphenol extract |
| Polyphenol extract medium dose | Experimental | 222mg single dose Receives: Dietary Supplement: Polyphenol extract |
| Polyphenol extract high dose | Experimental | 333mg single dose Receives: Dietary Supplement: Polyphenol extract |
| Placebo | Placebo comparator | Maltodextrin single dose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation
Acute change in endothelium-dependent flow-mediated dilation
Measured: Change over 2 hours post dose
Secondary outcomes (3)
Endothelium-independent vasodilation
Acute change in endothelium-independent vasodilation in response to Glyceryl trinitrate (GTN) drug
Measured: Change after 2 hours post dose
Systolic blood pressure
Measured by brachial cuff
Measured: Change over 2 hours post dose
Diastolic blood pressure
Measured by brachial cuff
Measured: Change over 2 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2021
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind placebo controlled dose-response crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma, Activ'inside
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220059
- Sponsor's protocol ID
- REC/21/0029
- Acronym
- Activ Acute
- Status last verified
- Mar 2022
- First submitted
- 26 Nov 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study
- ClinicalTrials.gov ID
- NCT05220059
- Acronym / sponsor ID
- Activ Acute / REC/21/0029
- Keywords
- Polyphenols, Cardiovascular Disease, Endothelial Function, Flow Mediated Dilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Parma, Activ'inside
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind placebo controlled dose-response crossover study
| Arm | Type | Receives |
|---|---|---|
| Polyphenol extract low dose | Experimental | Dietary Supplement: Polyphenol extract156mg single dose |
| Polyphenol extract medium dose | Experimental | Dietary Supplement: Polyphenol extract222mg single dose |
| Polyphenol extract high dose | Experimental | Dietary Supplement: Polyphenol extract333mg single dose |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin single dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphenol extractSingle dose | Dietary supplement | Polyphenol extract high dose, Polyphenol extract low dose, Polyphenol extract medium dose |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Flow Mediated Dilation
Time frame: Change over 2 hours post dose
Acute change in endothelium-dependent flow-mediated dilation
3 secondary outcomes
Endothelium-independent vasodilation
Time frame: Change after 2 hours post dose
Systolic blood pressure
Time frame: Change over 2 hours post dose
Diastolic blood pressure
Time frame: Change over 2 hours post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol extract in people with Cardiovascular Diseases and Endothelial Dysfunction, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Gill (+442870123181, c.gill@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow Mediated Dilation (time frame: Change over 2 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.