Bioefficacy of Phenolic Acids | NCT01781559

Studies
Bioefficacy of Phenolic Acids

NCT01781559

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Dec 12, 2013Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Endothelial Dysfunction

Interventions

phenolic acid

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 30, 2013

First Posted Date

Feb 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2013

Last Update Posted Date

Dec 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
phenolic acid	Dietary Supplement	phenolic acid	Maltodextrin flavanol + maltodextrin phenolic acid + maltodextrin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment		After 1 hour

Secondary Outcomes

Measure	Description	Time Frame
Change from predose in blood pressure at 0.5h		After 30 min

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Croft, Professor	School of Medicine and Pharmacology - University of WA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Medicine and Pharmacology - University of WA		Perth		6000	Australia