PFA-100 Responsive to Effect of Energy Drinks on Platelet Function

Study Overview
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Brief Summary
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This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the effect of energy drinks on platelet function. Participants' will have blood drawn prior to and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.

Detailed Description
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Two previous studies have demonstrated increased platelet aggregation 60 minutes after drinking a commercially available sugar-free energy drink. These studies utilized traditional platelet function studies, such as light transmission aggregometry (LTA), where platelet function is examined while adding varying concentrations of a panel of agonist to platelets. These studies are technically difficult, time intensive studies requiring specialized laboratories. They are relatively non-physiologic and do not mimic platelet response to vessel wall damage. Other tests better represent the reactions to vessel wall damage, including the PFA-100, which measures platelet aggregation and adhesion under conditions of high shear. Overall, PFA-100 is less expensive, requires less technical skill, and is less time consuming than LTA. It has been utilized in bleeding disorders and is demonstrating promise as a marker of thrombophilia. PFA-100 has demonstrated sensitivity to drug and dietary effects. It has also shown differences in closure time between sedentary and athletic individuals PFA-100 has not been used to investigate the effect of energy drinks.

Official Title
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Is the PFA-100 Responsive to the Effect of Energy Drinks on Platelet Function Changes?

Conditions
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Platelet Function, Thrombosis

Intervention / Treatment
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* Device: PFA-100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a history of consuming at least one energy drink beverage in the past 6 months without adverse effects; engage in moderate to strenuous physical activity more than 3 days per week. Exclusion Criteria: Known thromboembolic risk including protein C or S deficiency, anti-thrombin III deficiency, Factor V Leiden; history of thromboembolic event; current or previous anti-coagulation therapy, anti-platelet therapy, calcium antagonists; - current tricyclic antidepressant therapy, current selective serotonin re-uptake inhibitor therapy; antibiotic therapy; or famotidine therapy; acute illness; pregnancy; hemophilia; significant history of cardiovascular disease and/or diabetes mellitus; history of adverse effect of energy drinks. Inability to comply with pre-test dietary and activity requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Energy drink<br>Single group study. Platelet function analyzed with PFA-100 before and 60 minutes after ingestion of 250 ml sugar-free energy drink | Device: PFA-100<br>* The PFA-100 will be used to assess platelet function before and after energy drink consumption.<br>* Other names: Platelet function analyzer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure time | Agonist induced platelet activation and aggregation resulting in occlusion of the aperture and cessation of blood flow termed the closure time | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | one hour (every 15 minutes) | 
| pulse |  | one hour (every 15 minutes) |