Effect of Phenolic 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 phenolic acids on healthy volunteers.

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

Official Title
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Effect of Phenolic Acids on the Human Vasculature

Conditions
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Endothelial Dysfunction

Intervention / Treatment
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* Other: 43.3 mg hydrolyzed green coffee extract
* Other: 86.6 mg hydrolyzed green coffee extract
* Other: 173 mg hydrolyzed 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 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

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>* Reconstituted in water and given to subjects<br>* Other names: maltodextrin;|
| Experimental: 43.3 mg hydrolyzed green coffee extract<br>hydrolyzed green coffee extract as interventions | Other: 43.3 mg hydrolyzed green coffee extract<br>* Reconstituted in water and given to subjects<br>* Other names: Phenolic acid;|
| Experimental: 86.6 mg hydrolyzed green coffee extract<br>hydrolyzed green coffee extract as interventions | Other: 86.6 mg hydrolyzed green coffee extract<br>* Reconstituted in water and given to subjects<br>* Other names: Phenolic acid;|
| Experimental: 173 mg hydrolyzed green coffee extract<br>hydrolyzed green coffee extract as interventions | Other: 173 mg hydrolyzed green coffee extract<br>* Reconstituted in water and given to subjects<br>* Other names: Phenolic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Tmax | link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids | 6 hours | 
| Elimination half-life | link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids | 6 hours |