Endothelial DysfunctionNCT03599128
Effect of Phenolic Acids on the Human Vasculature
A study testing 43.3 mg hydrolyzed green coffee extract, 86.6 mg hydrolyzed green coffee extract and 173 mg hydrolyzed green coffee extract in people with Endothelial Dysfunction, run by Société des Produits Nestlé (SPN) at 1 site in Australia.
Trial summary
This study evaluates effects of different doses of phenolic acids on healthy volunteers. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- 43.3 mg hydrolyzed green coffee extract, 86.6 mg hydrolyzed green coffee extract and 173 mg hydrolyzed green coffee extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Mar 2018to 11 Dec 2018
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or postmenopausal female healthy volunteers aged 45-65 years old
- Willing and able to sign written informed consent prior to trial entry
- Healthy as determined by the medical history and physical examination
Who cannot join
- Premenopausal women
- Current smokers
- Abnormal blood pressure as defined as follow: systolic <90 or >140 mmHg and diastolic <60 or >90 mmHg
- Regular consumption of cholesterol-lowering medication
- Regular consumption of antihypertensive medication
- Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
Show all 11Show fewer
- Any food allergies
- Any intakes of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study
- Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
- Acute or chronic major psychiatric illness or other major illness that in the opinion of the investigator would make the subjects' participation in the study unsafe or prevent them from fully complying with the study procedures
- Body mass index (BMI) outside 18-32 kg/m2 range
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates effects of different doses of phenolic acids on healthy volunteers.
Read the detailed description
It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).
- Conditions
- Endothelial Dysfunction
- Being tested
- 43.3 mg hydrolyzed green coffee extract, 86.6 mg hydrolyzed green coffee extract, 173 mg hydrolyzed green coffee extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
43.3 mg hydrolyzed green coffee extractOther
Also called Phenolic acid
Reconstituted in water and given to subjects
86.6 mg hydrolyzed green coffee extractOther
Also called Phenolic acid
Reconstituted in water and given to subjects
173 mg hydrolyzed green coffee extractOther
Also called Phenolic acid
Reconstituted in water and given to subjects
PlaceboOther
Also called maltodextrin
Reconstituted in water and given to subjects
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| 43.3 mg hydrolyzed green coffee extract | Experimental | hydrolyzed green coffee extract as interventions Receives: Other: 43.3 mg hydrolyzed green coffee extract |
| 86.6 mg hydrolyzed green coffee extract | Experimental | hydrolyzed green coffee extract as interventions Receives: Other: 86.6 mg hydrolyzed green coffee extract |
| 173 mg hydrolyzed green coffee extract | Experimental | hydrolyzed green coffee extract as interventions Receives: Other: 173 mg hydrolyzed green coffee extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy by oral administration of phenolic acid in improving endothelial function
Average change from baseline in %FMD at any time point post treatment. Responses will be calculated as the percentage change in brachial artery diameter from baseline.
Measured: 6 hours
Secondary outcomes (3)
AUC(Area Under Curve) of the concentration/time curve
link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
Measured: 6 hours
Tmax
link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
Measured: 6 hours
Elimination half-life
link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start13 Mar 2018
- Primary completion4 Oct 2018
- Study completion11 Dec 2018
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.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie Tan, Study chair, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599128
- Sponsor's protocol ID
- 1717NRC
- Status last verified
- Jan 2019
- First submitted
- 1 Mar 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. 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
- NCT03599128
- Acronym / sponsor ID
- 1717NRC
- Conditions
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 26 Jul 2018 (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.
This study evaluates effects of different doses of phenolic acids on healthy volunteers.
Detailed description
It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| 43.3 mg hydrolyzed green coffee extract | Experimental | Other: 43.3 mg hydrolyzed green coffee extracthydrolyzed green coffee extract as interventions |
| 86.6 mg hydrolyzed green coffee extract | Experimental | Other: 86.6 mg hydrolyzed green coffee extracthydrolyzed green coffee extract as interventions |
| 173 mg hydrolyzed green coffee extract | Experimental | Other: 173 mg hydrolyzed green coffee extracthydrolyzed green coffee extract as interventions |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or postmenopausal female healthy volunteers aged 45-65 years old
- Willing and able to sign written informed consent prior to trial entry
- Healthy as determined by the medical history and physical examination
Key exclusion criteria (11 listed)
- Premenopausal women
- Current smokers
- Abnormal blood pressure as defined as follow: systolic <90 or >140 mmHg and diastolic <60 or >90 mmHg
- Regular consumption of cholesterol-lowering medication
- Regular consumption of antihypertensive medication
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 |
|---|---|---|
| 43.3 mg hydrolyzed green coffee extractAlso: Phenolic acidReconstituted in water and given to subjects | Other | 43.3 mg hydrolyzed green coffee extract |
| 86.6 mg hydrolyzed green coffee extractAlso: Phenolic acidReconstituted in water and given to subjects | Other | 86.6 mg hydrolyzed green coffee extract |
| 173 mg hydrolyzed green coffee extractAlso: Phenolic acidReconstituted in water and given to subjects | Other | 173 mg hydrolyzed green coffee extract |
| PlaceboAlso: maltodextrinReconstituted in water and given to subjects | Other | Placebo |
Primary outcome
Efficacy by oral administration of phenolic acid in improving endothelial function
Time frame: 6 hours
Average change from baseline in %FMD at any time point post treatment. Responses will be calculated as the percentage change in brachial artery diameter from baseline.
3 secondary outcomes
AUC(Area Under Curve) of the concentration/time curve
Time frame: 6 hours
Tmax
Time frame: 6 hours
Elimination half-life
Time frame: 6 hours
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 15 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Leslie Tan study chair
Société des Produits Nestlé (SPN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 43.3 mg hydrolyzed green coffee extract, 86.6 mg hydrolyzed green coffee extract and 173 mg hydrolyzed green coffee extract 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 3 inclusion and 11 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 15 Jan 2019. 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?
Efficacy by oral administration of phenolic acid in improving endothelial function (time frame: 6 hours). 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 15 Jan 2019.