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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03599128
Registration number
NCT03599128
Ethics application status
Date submitted
1/03/2018
Date registered
26/07/2018
Date last updated
15/01/2019
Titles & IDs
Public title
Effect of Phenolic Acids on the Human Vasculature
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Scientific title
Effect of Phenolic Acids on the Human Vasculature
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Secondary ID [1]
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1717NRC
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endothelial Dysfunction
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 43.3 mg hydrolyzed green coffee extract
Other interventions - 86.6 mg hydrolyzed green coffee extract
Other interventions - 173 mg hydrolyzed green coffee extract
Other interventions - Placebo
Placebo Comparator: Placebo - Placebo
Experimental: 43.3 mg hydrolyzed green coffee extract - hydrolyzed green coffee extract as interventions
Experimental: 86.6 mg hydrolyzed green coffee extract - hydrolyzed green coffee extract as interventions
Experimental: 173 mg hydrolyzed green coffee extract - hydrolyzed green coffee extract as interventions
Other interventions: 43.3 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
Other interventions: 86.6 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
Other interventions: 173 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
Other interventions: Placebo
Reconstituted in water and given to subjects
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy by oral administration of phenolic acid in improving endothelial function
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Assessment method [1]
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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.
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Timepoint [1]
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6 hours
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Secondary outcome [1]
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AUC(Area Under Curve) of the concentration/time curve
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Assessment method [1]
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link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
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Timepoint [1]
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6 hours
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Secondary outcome [2]
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Tmax
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Assessment method [2]
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link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
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Timepoint [2]
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6 hours
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Secondary outcome [3]
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Elimination half-life
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Assessment method [3]
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link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
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Timepoint [3]
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6 hours
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Eligibility
Key inclusion criteria
- 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
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Minimum age
45
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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
- 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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/12/2018
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
Pert
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Recruitment hospital [1]
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University of Western Australia - Crawley
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Recruitment postcode(s) [1]
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6009 - Crawley
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Société des Produits Nestlé (SPN)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study evaluates effects of different doses of phenolic acids on healthy volunteers.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03599128
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Leslie Tan
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Address
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Société des Produits Nestlé (SPN)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03599128
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