Bioefficacy of Phenolic Acids

Not Applicable

Completed

• Conditions: Endothelial Dysfunction
• Interventions: Dietary Supplement: phenolic acid

• Registration Number: NCT01781559
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Primary Completion: 2013-08
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
phenolic acid + maltodextrin	phenolic acid	phenolic acid + maltodextrin;
Maltodextrin	phenolic acid	Maltodextrin
flavanol + maltodextrin	phenolic acid	flavanol + maltodextrin

Primary Outcome Measures

Name	Time	Method
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment	After 1 hour

Secondary Outcome Measures

Name	Time	Method
Change from predose in blood pressure at 0.5h	After 30 min

Trial Locations

Locations (1)

School of Medicine and Pharmacology - University of WA; 🇦🇺 Perth, Australia