Effect of Chlorogenic Acids on the Human Vasculature

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

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction
• Intervention / Treatment: Other: Placebo; Other: Green coffee extract

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Perth
    • Crawley, Perth, Australia, 6009
      • University of Western Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: 302 mg green coffee extract; Green coffee extract	Other: Green coffee extract; Reconstituted in water and given to subjects
Experimental: 604 mg green coffee extract; Green coffee extract	Other: Green coffee extract; Reconstituted in water and given to subjects
Experimental: 906 mg green coffee extract; Green coffee extract	Other: Green coffee extract; Reconstituted in water and given to subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood concentrations in plasma.	Blood concentrations in plasma.	24 hours
Safety of the investigational product	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	from first dose till last visit

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Chair: Leslie Tan, Nestle

Publications and helpful links

General Publications

• Naylor LH, Zimmermann D, Guitard-Uldry M, Poquet L, Lévêques A, Eriksen B, Bel Rhlid R, Galaffu N, D'Urzo C, De Castro A, Van Schaick E, Green DJ, Actis-Goretta L. Acute dose-response effect of coffee-derived chlorogenic acids on the human vasculature in healthy volunteers: a randomized controlled trial. Am J Clin Nutr. 2021 Feb 2;113(2):370-379. doi: 10.1093/ajcn/nqaa312.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2018
• Primary Completion (Actual): November 7, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1716NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No