HealthyNCT01772784
Effects of Phenolic Acids on Endothelial Function
A study testing Phenolic acids in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as tea, coffee, red wine, and chocolate. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Phenolic acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Nov 2012
- 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 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- males
- Smokers
Who cannot join
- Any food allergy
- Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg
- Regular consumption of medication within 2 months before the study inclusion
- Caffeine intake 1 day before screening measurements (and 1 day before each visit),
- Any 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Cardiovascular Center Bern, University Hospital
Bern, 3010
About this study
Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as tea, coffee, red wine, and chocolate. The aim of the present study is to investigate whether endothelial function is altered by ingestion of phenolic acids. Moreover, the investigators will evaluate the effect of phenolic acids on blood pressure and platelet adhesion.
- Conditions
- Healthy
- Being tested
- Phenolic acids
- Keywords
- subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenolic acidsOther
Phenolic acids
| Study group | Role | What they receive |
|---|---|---|
| phenolic acids | Experimental | Maltodextrine + Phenolic acids Receives: Other: Phenolic acids |
| placebo | Placebo comparator | Maltodextrine Receives: Other: Phenolic acids |
| phenolic acid | Experimental | Maltodextrine + Phenolic acids Receives: Other: Phenolic acids |
| polyphenol | Active comparator | Not described Receives: Other: Phenolic acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial dysfunction
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Allemann, MD, Prof., Principal investigator, University Hospital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772784
- Sponsor's protocol ID
- 11.36.NRC
- Status last verified
- Nov 2012
- First submitted
- 25 Jul 2012
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mills CE, Flury A, Marmet C, Poquet L, Rimoldi SF, Sartori C, Rexhaj E, Brenner R, Allemann Y, Zimmermann D, Gibson GR, Mottram DS, Oruna-Concha MJ, Actis-Goretta L, Spencer JPE. Mediation of coffee-induced improvements in human vascular function by chlorogenic acids and its metabolites: Two randomized, controlled, crossover intervention trials. Clin Nutr. 2017 Dec;36(6):1520-1529. doi: 10.1016/j.clnu.2016.11.013. Epub 2016 Nov 30.
PubMed 28012692
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phenolic Acids on Endothelial Function
- ClinicalTrials.gov ID
- NCT01772784
- Acronym / sponsor ID
- 11.36.NRC
- Conditions
- Healthy
- Keywords
- subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 Jan 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.
Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as tea, coffee, red wine, and chocolate. The aim of the present study is to investigate whether endothelial function is altered by ingestion of phenolic acids. Moreover, the investigators will evaluate the effect of phenolic acids on blood pressure and platelet adhesion.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| phenolic acids | Experimental | Other: Phenolic acidsMaltodextrine + Phenolic acids |
| placebo | Placebo comparator | Other: Phenolic acidsMaltodextrine |
| phenolic acid | Experimental | Other: Phenolic acidsMaltodextrine + Phenolic acids |
| polyphenol | Active comparator | Other: Phenolic acids |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- males
- Smokers
Key exclusion criteria (6 listed)
- Any food allergy
- Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg
- Regular consumption of medication within 2 months before the study inclusion
- Caffeine intake 1 day before screening measurements (and 1 day before each visit),
- Any intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.
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 acidsPhenolic acids | Other | phenolic acid, phenolic acids, placebo, polyphenol |
Primary outcome
endothelial dysfunction
Time frame: 1 hour
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 21 Jan 2013.
- Derived from this study: PubMed 28012692Mills CE, Flury A, Marmet C, Poquet L, Rimoldi SF, Sartori C, Rexhaj E, Brenner R, Allemann Y, Zimmermann D, Gibson GR, Mottram DS, Oruna-Concha MJ, Actis-Goretta L, Spencer JPE. Mediation of coffee-induced improvements in human vascular function by chlorogenic acids and its metabolites: Two randomized, controlled, crossover intervention trials. Clin Nutr. 2017 Dec;36(6):1520-1529. doi: 10.1016/j.clnu.2016.11.013. Epub 2016 Nov 30.
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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.
Yves Allemann, MD, Prof. principal investigator
University Hospital, Bern, Switzerland
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 acids in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 3 inclusion and 6 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 21 Jan 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 Switzerland. 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?
endothelial dysfunction (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772784, which also lists 1 linked publication.
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 21 Jan 2013.