Effect of Phenolic Acids on the Human Vasculature

NCT ID: NCT03599128

Last Updated: 2019-01-15

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-13

Study Completion Date

2018-12-11

Brief Summary

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This study evaluates effects of different doses of phenolic acids on healthy volunteers.

Detailed Description

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It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).

Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Reconstituted in water and given to subjects

43.3 mg hydrolyzed green coffee extract

hydrolyzed green coffee extract as interventions

Group Type EXPERIMENTAL

43.3 mg hydrolyzed green coffee extract

Intervention Type OTHER

Reconstituted in water and given to subjects

86.6 mg hydrolyzed green coffee extract

hydrolyzed green coffee extract as interventions

Group Type EXPERIMENTAL

86.6 mg hydrolyzed green coffee extract

Intervention Type OTHER

Reconstituted in water and given to subjects

173 mg hydrolyzed green coffee extract

hydrolyzed green coffee extract as interventions

Group Type EXPERIMENTAL

173 mg hydrolyzed green coffee extract

Intervention Type OTHER

Reconstituted in water and given to subjects

Interventions

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43.3 mg hydrolyzed green coffee extract

Reconstituted in water and given to subjects

Intervention Type OTHER

86.6 mg hydrolyzed green coffee extract

Reconstituted in water and given to subjects

Intervention Type OTHER

173 mg hydrolyzed green coffee extract

Reconstituted in water and given to subjects

Intervention Type OTHER

Placebo

Reconstituted in water and given to subjects

Intervention Type OTHER

Other Intervention Names

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Phenolic acid Phenolic acid Phenolic acid maltodextrin

Eligibility Criteria

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Inclusion Criteria

* Male or postmenopausal female healthy volunteers aged 45-65 years old
* Willing and able to sign written informed consent prior to trial entry
* Healthy as determined by the medical history and physical examination

Exclusion Criteria

* Premenopausal women
* Current smokers
* Abnormal blood pressure as defined as follow: systolic \<90 or \>140 mmHg and diastolic \<60 or \>90 mmHg
* Regular consumption of cholesterol-lowering medication
* Regular consumption of antihypertensive medication
* Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
* Any food allergies
* Any intakes of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study
* Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
* Acute or chronic major psychiatric illness or other major illness that in the opinion of the investigator would make the subjects' participation in the study unsafe or prevent them from fully complying with the study procedures
* Body mass index (BMI) outside 18-32 kg/m2 range
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

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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Leslie Tan

Role: STUDY_CHAIR

Société des Produits Nestlé (SPN)

Locations

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University of Western Australia

Crawley, Perth, Australia

Site Status

Countries

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Australia

Other Identifiers

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1717NRC

Identifier Type: -

Identifier Source: org_study_id

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