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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03599128




Registration number
NCT03599128
Ethics application status
Date submitted
1/03/2018
Date registered
26/07/2018

Titles & IDs
Public title
Effect of Phenolic Acids on the Human Vasculature
Scientific title
Effect of Phenolic Acids on the Human Vasculature
Secondary ID [1] 0 0
1717NRC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial Dysfunction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy by oral administration of phenolic acid in improving endothelial function
Timepoint [1] 0 0
6 hours
Secondary outcome [1] 0 0
AUC(Area Under Curve) of the concentration/time curve
Timepoint [1] 0 0
6 hours
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
6 hours
Secondary outcome [3] 0 0
Elimination half-life
Timepoint [3] 0 0
6 hours

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
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2018
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Pert
Recruitment hospital [1] 0 0
University of Western Australia - Crawley
Recruitment postcode(s) [1] 0 0
6009 - Crawley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Société des Produits Nestlé (SPN)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leslie Tan
Address 0 0
Société des Produits Nestlé (SPN)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03599128