NCT01781559

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

January 28, 2013

Last Update Submit

December 11, 2013

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment

    After 1 hour

Secondary Outcomes (1)

  • Change from predose in blood pressure at 0.5h

    After 30 min

Study Arms (3)

phenolic acid + maltodextrin

EXPERIMENTAL

phenolic acid + maltodextrin;

Dietary Supplement: phenolic acid

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: phenolic acid

flavanol + maltodextrin

ACTIVE COMPARATOR

flavanol + maltodextrin

Dietary Supplement: phenolic acid

Interventions

phenolic acidDIETARY_SUPPLEMENT

phenolic acid

Maltodextrinflavanol + maltodextrinphenolic acid + maltodextrin

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine and Pharmacology - University of WA

Perth, 6000, Australia

Location

MeSH Terms

Interventions

phenolic acid

Study Officials

  • Kevin Croft, Professor

    School of Medicine and Pharmacology - University of WA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 1, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

AU(1)