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Completed

NCT Number: NCT02997111

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University

St Louis, Missouri, 63104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PFA-100

Device

The PFA-100 will be used to assess platelet function before and after energy drink consumption.

Other names: Platelet function analyzer

Primary outcomes

  1. Closure time

    Time frame: one hour

    Agonist induced platelet activation and aggregation resulting in occlusion of the aperture and cessation of blood flow termed the closure time

Secondary outcomes

  1. blood pressure

    Time frame: one hour (every 15 minutes)

  2. pulse

    Time frame: one hour (every 15 minutes)

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2016
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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