Bioefficacy of Phenolic Acids

Endothelial Dysfunction Clinical Trial

Official title:

Effect of Phenolic Acids on the Human Vasculature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781559
• Other study ID #: 11.35.NRC
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: December 11, 2013
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Dietary Supplement:
• phenolic acid
phenolic acid

Locations

Country	Name	City	State
Australia	School of Medicine and Pharmacology - University of WA	Perth

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment		After 1 hour	No
Secondary	Change from predose in blood pressure at 0.5h		After 30 min	No