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CompletedNCT01781559Updated Dec 12, 2013

Bioefficacy of Phenolic Acids

An interventional study of phenolic acid in Endothelial Dysfunction, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Australia. Per ClinicalTrials.gov, last updated 2013-12-12.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Sex
All
01

Study summary

The objective is to demonstrate the effect of phenolic acids on endothelial function.

02

Conditions studied

  • Endothelial Dysfunction
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    phenolic acid + maltodextrin

    phenolic acid + maltodextrin;

    Dietary Supplement: phenolic acid

  • Placebo comparator
    Maltodextrin

    Maltodextrin

    Dietary Supplement: phenolic acid

  • Active comparator
    flavanol + maltodextrin

    flavanol + maltodextrin

    Dietary Supplement: phenolic acid

Interventions

  • Dietary supplementphenolic acid

    phenolic acid

06

What researchers measure

Primary outcomes

  1. Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment

    Time frame: After 1 hour

Secondary outcomes

  1. Change from predose in blood pressure at 0.5h

    Time frame: After 30 min

07

Study locations

1 site
  • School of Medicine and Pharmacology - University of WA
    Perth, 6000, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01781559
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Feb 1, 2013
Start date
Oct 2012
Primary completion
Aug 2013
Completion
Dec 2013
Last update
Dec 12, 2013

Study contacts

Kevin Croft, Professor
principal investigator · School of Medicine and Pharmacology - University of WA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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