NCT01772784

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
Last Updated

January 21, 2013

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

July 25, 2012

Last Update Submit

January 17, 2013

Conditions

Healthy

Keywords

subjects

Outcome Measures

Primary Outcomes (1)

  • endothelial dysfunction

    1 hour

Study Arms (4)

phenolic acids

EXPERIMENTAL

Maltodextrine + Phenolic acids

Other: Phenolic acids

placebo

PLACEBO COMPARATOR

Maltodextrine

Other: Phenolic acids

phenolic acid

EXPERIMENTAL

Maltodextrine + Phenolic acids

Other: Phenolic acids

polyphenol

ACTIVE COMPARATOR
Other: Phenolic acids

Interventions

Phenolic acidsOTHER

Phenolic acids

phenolic acidphenolic acidsplacebopolyphenol

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • males
  • Smokers

You may not qualify if:

  • Any food allergy
  • Abnormal blood pressure defined as follow: systolic \<100 or \>160 mmHg and diastolic \<50 or \>100mmHg
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Cardiovascular Center Bern, University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Mills CE, Flury A, Marmet C, Poquet L, Rimoldi SF, Sartori C, Rexhaj E, Brenner R, Allemann Y, Zimmermann D, Gibson GR, Mottram DS, Oruna-Concha MJ, Actis-Goretta L, Spencer JPE. Mediation of coffee-induced improvements in human vascular function by chlorogenic acids and its metabolites: Two randomized, controlled, crossover intervention trials. Clin Nutr. 2017 Dec;36(6):1520-1529. doi: 10.1016/j.clnu.2016.11.013. Epub 2016 Nov 30.

    PMID: 28012692DERIVED

Study Officials

  • Yves Allemann, MD, Prof.

    University Hospital, Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

January 21, 2013

Study Start

June 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 21, 2013

Record last verified: 2012-11

Locations

CH(1)