Clinical trial NCT02997111: PFA-100 Responsive to Effect of Energy Drinks on Platelet Function
Official title: Is the PFA-100 Responsive to the Effect of Energy Drinks on Platelet Function Changes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Function
Thrombosis
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Closure time
timeFrame: one hour
Secondary outcomes:
measure: blood pressure
timeFrame: one hour (every 15 minutes)
measure: pulse
timeFrame: one hour (every 15 minutes)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Katherine Newsham, PhD
role: PRINCIPAL_INVESTIGATOR
References: