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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
Not applicable
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
The objective is to demonstrate the effect of phenolic acids on endothelial function.
Trial website
https://clinicaltrials.gov/study/NCT01781559
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01781559