Bioefficacy of Phenolic Acids

December 11, 2013 updated by: Nestlé

Effect of Phenolic Acids on the Human Vasculature

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Maltodextrin
Dietary supplement: phenolic acid
phenolic acid
Experimental: phenolic acid + maltodextrin
phenolic acid + maltodextrin;
Dietary supplement: phenolic acid
phenolic acid
Active Comparator: flavanol + maltodextrin
Dietary supplement: phenolic acid
phenolic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
Time Frame: After 1 hour
After 1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from predose in blood pressure at 0.5h
Time Frame: After 30 min
After 30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Kevin Croft, Professor, School of Medicine and Pharmacology - University of WA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 12, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 11.35.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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