Effect of Chlorogenic Acids on the Human Vasculature

Not Applicable

Completed

• Conditions: Endothelial Dysfunction
• Interventions: Other: Green coffee extract; Other: Placebo

• Registration Number: NCT03520452
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This study evaluates effects of different doses of chlorogenic acids on vascular health.

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-03-01
• Study Start: 2018-03-14
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-09
• Primary Completion: 2018-11-07
• Study Completion: 2018-12-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
604 mg green coffee extract	Green coffee extract	Green coffee extract
Placebo	Placebo	Placebo
906 mg green coffee extract	Green coffee extract	Green coffee extract
302 mg green coffee extract	Green coffee extract	Green coffee extract

Primary Outcome Measures

Name	Time	Method
Efficacy by oral administration of chlorogenic acid in improving endothelial function	24 hours	The primary outcome will be the average change from baseline (i.e. predose) in the %Flow Mediated Dilation

Secondary Outcome Measures

Name	Time	Method
Tmax	24 hours	link for endothelial function improvement
Cmax of the different chlorogenic acid metabolites	24 hours	link for endothelial function improvement
Area Under Curve of the concentration/time curve	24 hours	Area Under Curve of the concentration/time curve
elimination half-life.	24 hours	link for endothelial function improvement

Trial Locations

Locations (1)

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