Effect of Phenolic Acids on the Human Vasculature

Endothelial Dysfunction Clinical Trial

Official title:

Effect of Phenolic Acids on the Human Vasculature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599128
• Other study ID #: 1717NRC
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: December 11, 2018

Study information

• Verified date: January 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 11, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Other:
• 43.3 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
• 86.6 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
• 173 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
• Placebo
Reconstituted in water and given to subjects

Locations

Country	Name	City	State
Australia	University of Western Australia	Crawley	Perth

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood concentrations in plasma.	Blood concentrations in plasma.	6 hours
Other	To investigate safety of investigational products: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	through study completion, an average of 1 year.
Primary	Efficacy by oral administration of phenolic acid in improving endothelial function	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.	6 hours
Secondary	AUC(Area Under Curve) of the concentration/time curve	link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids	6 hours
Secondary	Tmax	link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids	6 hours
Secondary	Elimination half-life	link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids	6 hours