Effect of Chlorogenic Acids on the Human Vasculature

Endothelial Dysfunction Clinical Trial

Official title:

Effect of Chlorogenic Acids on the Human Vasculature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520452
• Other study ID #: 1716NRC
• Status: Completed
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: December 20, 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 chlorogenic acids on vascular health.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 20, 2018
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or postmenopausal female healthy volunteers aged 45-65 years old

2. Willing and able to sign written informed consent prior to trial entry

3. Healthy as determined by the medical history and physical examination

Exclusion Criteria:

1. Premenopausal women

2. Current smokers

3. Abnormal blood pressure, defined as follow: systolic <90 or >140 mmHg and diastolic <60 or >90 mmHg

4. Regular consumption of cholesterol-lowering medication

5. Regular consumption of antihypertensive medication

6. Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment

7. Any food allergies

8. Any intakes of multivitamin-tablets and other supplemental compounds within 10 days of the study start and throughout the study

9. Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits

10. 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

11. Use of medication to treat psychiatric illness (depression) within 3 months prior to the study

12. Recent significant weight loss or gain (>6% of body weight) in the past 3 months

13. Body mass index (BMI) outside 18-32 kg/m2 range

14. Alcohol intake > 280g/week (21-28 glasses per week)

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Other:
• Green coffee extract
Reconstituted in water and given to subjects
• Placebo
Placebo

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.	24 hours
Other	Safety of the investigational product	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	from first dose till last visit
Primary	Efficacy by oral administration of chlorogenic acid in improving endothelial function	The primary outcome will be the average change from baseline (i.e. predose) in the %Flow Mediated Dilation	24 hours
Secondary	Cmax of the different chlorogenic acid metabolites	link for endothelial function improvement	24 hours
Secondary	Area Under Curve of the concentration/time curve	Area Under Curve of the concentration/time curve	24 hours
Secondary	Tmax	link for endothelial function improvement	24 hours
Secondary	elimination half-life.	link for endothelial function improvement	24 hours