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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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02997111
Enrollment
13
Registered
2016-12-19
Start date
2017-02-14
Completion date
2017-06-20
Last updated
2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet Function, Thrombosis

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.

Interventions

DEVICEPFA-100

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

Sponsors

St. Louis University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Closure timeone hourAgonist induced platelet activation and aggregation resulting in occlusion of the aperture and cessation of blood flow termed the closure time

Secondary

MeasureTime frame
blood pressureone hour (every 15 minutes)
pulseone hour (every 15 minutes)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026