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

Not Applicable

Completed

• Conditions: Platelet Function; Thrombosis
• Interventions: Device: PFA-100

• Registration Number: NCT02997111
• Lead Sponsor: St. Louis University

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.

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-19
• Study Start: 2017-02-14
• Status Verified: 2017-06
• Primary Completion: 2017-06-09
• Study Completion: 2017-06-20
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Energy drink	PFA-100	Single group study. Platelet function analyzed with PFA-100 before and 60 minutes after ingestion of 250 ml sugar-free energy drink

Primary Outcome Measures

Name	Time	Method
Closure time	one hour	Agonist induced platelet activation and aggregation resulting in occlusion of the aperture and cessation of blood flow termed the closure time

Secondary Outcome Measures

Name	Time	Method
blood pressure	one hour (every 15 minutes)
pulse	one hour (every 15 minutes)

Trial Locations

Locations (1)

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States