Endothelial DysfunctionNCT01781559
Bioefficacy of Phenolic Acids
A study testing phenolic acid in people with Endothelial Dysfunction, run by Société des Produits Nestlé (SPN) at 1 site in Australia.
Trial summary
The objective is to demonstrate the effect of phenolic acids on endothelial function. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- phenolic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2012to Dec 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy, Men and women
- Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening
Who cannot join
- Any food allergy
- Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg
- Pregnancy or lactating women
- Regular consumption of cholesterol-lowering or antihypertensive medication
- Smokers
- Inability to restrain from caffeine/tea and alcohol for 12hrs prior to study visits (intake1 day before screening measurements (and 1 day before each visit)
- Not restrain the intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.
- Excessive alcohol intake defined as > 280 g per week for men and >210g per week for women
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Medicine and Pharmacology - University of WA
Perth, 6000
About this study
Official title: Effect of Phenolic Acids on the Human Vasculature
The objective is to demonstrate the effect of phenolic acids on endothelial function.
- Conditions
- Endothelial Dysfunction
- Being tested
- phenolic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenolic acidDietary supplement
phenolic acid
| Study group | Role | What they receive |
|---|---|---|
| phenolic acid + maltodextrin | Experimental | phenolic acid + maltodextrin; Receives: Dietary Supplement: phenolic acid |
| Maltodextrin | Placebo comparator | Maltodextrin Receives: Dietary Supplement: phenolic acid |
| flavanol + maltodextrin | Active comparator | flavanol + maltodextrin Receives: Dietary Supplement: phenolic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
Measured: After 1 hour
Secondary outcomes (1)
Change from predose in blood pressure at 0.5h
Measured: After 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Croft, Professor, Principal investigator, School of Medicine and Pharmacology - University of WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781559
- Sponsor's protocol ID
- 11.35.NRC
- Status last verified
- Dec 2013
- First submitted
- 28 Jan 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phenolic Acids on the Human Vasculature
- ClinicalTrials.gov ID
- NCT01781559
- Acronym / sponsor ID
- 11.35.NRC
- Conditions
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Feb 2013 (estimated)
- 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.
The objective is to demonstrate the effect of phenolic acids on endothelial function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| phenolic acid + maltodextrin | Experimental | Dietary Supplement: phenolic acidphenolic acid + maltodextrin; |
| Maltodextrin | Placebo comparator | Dietary Supplement: phenolic acidMaltodextrin |
| flavanol + maltodextrin | Active comparator | Dietary Supplement: phenolic acidflavanol + maltodextrin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy, Men and women
- Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening
Key exclusion criteria (8 listed)
- Any food allergy
- Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg
- Pregnancy or lactating women
- Regular consumption of cholesterol-lowering or antihypertensive medication
- Smokers
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 |
|---|---|---|
| phenolic acidphenolic acid | Dietary supplement | Maltodextrin, flavanol + maltodextrin, phenolic acid + maltodextrin |
Primary outcome
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
Time frame: After 1 hour
1 secondary outcome
Change from predose in blood pressure at 0.5h
Time frame: After 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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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.
Kevin Croft, Professor principal investigator
School of Medicine and Pharmacology - University of WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phenolic acid in people with Endothelial Dysfunction, run by Société des Produits Nestlé (SPN) at 1 site in Australia.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 12 Dec 2013. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment (time frame: After 1 hour). 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 12 Dec 2013.