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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01781559




Registration number
NCT01781559
Ethics application status
Date submitted
28/01/2013
Date registered
1/02/2013
Date last updated
12/12/2013

Titles & IDs
Public title
Bioefficacy of Phenolic Acids
Scientific title
Effect of Phenolic Acids on the Human Vasculature
Secondary ID [1] 0 0
11.35.NRC
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
Treatment: Other - phenolic acid

Experimental: phenolic acid + maltodextrin - phenolic acid + maltodextrin;

Placebo comparator: Maltodextrin - Maltodextrin

Active comparator: flavanol + maltodextrin - flavanol + maltodextrin


Treatment: Other: phenolic acid
phenolic acid
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
Timepoint [1] 0 0
After 1 hour
Secondary outcome [1] 0 0
Change from predose in blood pressure at 0.5h
Timepoint [1] 0 0
After 30 min

Eligibility
Key inclusion criteria
* 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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

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
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
School of Medicine and Pharmacology - University of WA - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

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
Kevin Croft, Professor
Address 0 0
School of Medicine and Pharmacology - University of WA
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

No information has been provided regarding IPD availability


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/NCT01781559