Bioefficacy of Phenolic Acids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01781559
First received: January 28, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Endothelial Dysfunction
Dietary Supplement: phenolic acid

Study Type: Interventional
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
Official Title: Effect of Phenolic Acids on the Human Vasculature

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment [ Time Frame: After 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from predose in blood pressure at 0.5h [ Time Frame: After 30 min ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: phenolic acid + maltodextrin
phenolic acid + maltodextrin;
Dietary Supplement: phenolic acid
phenolic acid
Placebo Comparator: Maltodextrin
Maltodextrin
Dietary Supplement: phenolic acid
phenolic acid
Active Comparator: flavanol + maltodextrin
flavanol + maltodextrin
Dietary Supplement: phenolic acid
phenolic acid

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781559

Locations
Australia
School of Medicine and Pharmacology - University of WA
Perth, Australia, 6000
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Kevin Croft, Professor School of Medicine and Pharmacology - University of WA
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01781559     History of Changes
Other Study ID Numbers: 11.35.NRC
Study First Received: January 28, 2013
Last Updated: December 11, 2013
Health Authority: Australia: Human Research Ethics Committee

ClinicalTrials.gov processed this record on April 23, 2014