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

Primary Purpose

Platelet Function, Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PFA-100
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Platelet Function

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Saint Louis University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Energy drink

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blood pressure
pulse

Full Information

First Posted
December 15, 2016
Last Updated
June 21, 2017
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT02997111
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
June 9, 2017 (Actual)
Study Completion Date
June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Function, Thrombosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Energy drink
Arm Type
Other
Arm Description
Single group study. Platelet function analyzed with PFA-100 before and 60 minutes after ingestion of 250 ml sugar-free energy drink
Intervention Type
Device
Intervention Name(s)
PFA-100
Other Intervention Name(s)
Platelet function analyzer
Intervention Description
The PFA-100 will be used to assess platelet function before and after energy drink consumption.
Primary Outcome Measure Information:
Title
Closure time
Description
Agonist induced platelet activation and aggregation resulting in occlusion of the aperture and cessation of blood flow termed the closure time
Time Frame
one hour
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
one hour (every 15 minutes)
Title
pulse
Time Frame
one hour (every 15 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Newsham, PhD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data with other researchers

Learn more about this trial

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

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