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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014