Effect of Chlorogenic Acids on the Human Vasculature

Study Overview
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Brief Summary
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This study evaluates effects of different doses of chlorogenic acids on vascular health.

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

Official Title
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Effect of Chlorogenic Acids on the Human Vasculature

Conditions
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Endothelial Dysfunction

Intervention / Treatment
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* Other: Green coffee extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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, 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 within 10 days of 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 Use of medication to treat psychiatric illness (depression) within 3 months prior to the study Recent significant weight loss or gain (>6% of body weight) in the past 3 months Body mass index (BMI) outside 18-32 kg/m2 range Alcohol intake > 280g/week (21-28 glasses per week)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|
| Experimental: 302 mg green coffee extract<br>Green coffee extract | Other: Green coffee extract<br>* Reconstituted in water and given to subjects<br>|
| Experimental: 604 mg green coffee extract<br>Green coffee extract | Other: Green coffee extract<br>* Reconstituted in water and given to subjects<br>|
| Experimental: 906 mg green coffee extract<br>Green coffee extract | Other: Green coffee extract<br>* Reconstituted in water and given to subjects<br>|

What is the study measuring?
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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 |