We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioefficacy of Phenolic Acids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781559
First Posted: February 1, 2013
Last Update Posted: December 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Change from predose in blood pressure at 0.5h [ Time Frame: After 30 min ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01781559     History of Changes
Other Study ID Numbers: 11.35.NRC
First Submitted: January 28, 2013
First Posted: February 1, 2013
Last Update Posted: December 12, 2013
Last Verified: December 2013