Effect of Phenolic Acids on the Human Vasculature

Not Applicable

Completed

• Conditions: Endothelial Dysfunction
• Interventions: Other: 86.6 mg hydrolyzed green coffee extract; Other: 43.3 mg hydrolyzed green coffee extract; Other: Placebo; Other: 173 mg hydrolyzed green coffee extract

• Registration Number: NCT03599128
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-03-01
• Study Start: 2018-03-13
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Primary Completion: 2018-10-04
• Study Completion: 2018-12-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
86.6 mg hydrolyzed green coffee extract	86.6 mg hydrolyzed green coffee extract	hydrolyzed green coffee extract as interventions
43.3 mg hydrolyzed green coffee extract	43.3 mg hydrolyzed green coffee extract	hydrolyzed green coffee extract as interventions
Placebo	Placebo	Placebo
173 mg hydrolyzed green coffee extract	173 mg hydrolyzed green coffee extract	hydrolyzed green coffee extract as interventions

Primary Outcome Measures

Name	Time	Method
Efficacy by oral administration of phenolic acid in improving endothelial function	6 hours	Average change from baseline in %FMD at any time point post treatment. Responses will be calculated as the percentage change in brachial artery diameter from baseline.

Secondary Outcome Measures

Name	Time	Method
Elimination half-life	6 hours	link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
Tmax	6 hours	link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids
AUC(Area Under Curve) of the concentration/time curve	6 hours	link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids

Trial Locations

Locations (1)

University of Western Australia; 🇦🇺 Crawley, Perth, Australia