Bioefficacy of Phenolic Acids

NCT ID: NCT01781559

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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phenolic acid + maltodextrin

phenolic acid + maltodextrin;

Group Type EXPERIMENTAL

phenolic acid

Intervention Type DIETARY_SUPPLEMENT

phenolic acid

Maltodextrin

Maltodextrin

Group Type PLACEBO_COMPARATOR

phenolic acid

Intervention Type DIETARY_SUPPLEMENT

phenolic acid

flavanol + maltodextrin

flavanol + maltodextrin

Group Type ACTIVE_COMPARATOR

phenolic acid

Intervention Type DIETARY_SUPPLEMENT

phenolic acid

Interventions

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phenolic acid

phenolic acid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Croft, Professor

Role: PRINCIPAL_INVESTIGATOR

School of Medicine and Pharmacology - University of WA

Locations

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School of Medicine and Pharmacology - University of WA

Perth, , Australia

Site Status

Countries

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Australia

Other Identifiers

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11.35.NRC

Identifier Type: -

Identifier Source: org_study_id