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Effects of Phenolic Acids on Endothelial Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01772784
First received: July 25, 2012
Last updated: January 17, 2013
Last verified: November 2012
History of Changes
  Purpose

Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as tea, coffee, red wine, and chocolate. The aim of the present study is to investigate whether endothelial function is altered by ingestion of phenolic acids. Moreover, the investigators will evaluate the effect of phenolic acids on blood pressure and platelet adhesion.


Condition Intervention
Healthy
 Other: Phenolic acids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • endothelial dysfunction [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: phenolic acids
Maltodextrine + Phenolic acids
 Other: Phenolic acids
Phenolic acids
Placebo Comparator: placebo
Maltodextrine
 Other: Phenolic acids
Phenolic acids
Experimental: phenolic acid
Maltodextrine + Phenolic acids
 Other: Phenolic acids
Phenolic acids
Active Comparator: polyphenol Other: Phenolic acids
Phenolic acids

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • males
  • Smokers

Exclusion Criteria:

Any food allergy

  • Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg
  • Regular consumption of medication within 2 months before the study inclusion
  • Caffeine intake 1 day before screening measurements (and 1 day before each visit),
  • Any 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772784

Locations
Switzerland
Swiss Cardiovascular Center Bern, University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Yves Allemann, MD, Prof. University Hospital, Bern, Switzerland
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01772784     History of Changes
Other Study ID Numbers: 11.36.NRC
Study First Received: July 25, 2012
Last Updated: January 17, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Nestlé:
subjects

ClinicalTrials.gov processed this record on May 23, 2013