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

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis; Platelet Function
• Intervention / Treatment: Device: PFA-100

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Energy drink; 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; The PFA-100 will be used to assess platelet function before and after energy drink consumption.; Other Names: Platelet function analyzer

What is the study measuring?

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	Time Frame
blood pressure	one hour (every 15 minutes)
pulse	one hour (every 15 minutes)

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Katherine Newsham, PhD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): June 9, 2017
• Study Completion (Actual): June 20, 2017

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 27619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share individual participant data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No