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OpenTrials
Completed

NCT Number: NCT01781559

Bioefficacy of Phenolic Acids

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

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Key information

Conditions

Endothelial Dysfunction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine and Pharmacology - University of WA

Perth, 6000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

phenolic acid

Dietary Supplement

phenolic acid

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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effect of Phenolic Acids on the Human Vasculature

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2013
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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