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

NCT02997111 | Completed

• 1 other identifier: 27619
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Function; Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• blood pressure

  one hour (every 15 minutes)

• pulse

  one hour (every 15 minutes)

Study Arms (1)

Energy drink

OTHER

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

Interventions

PFA-100 DEVICE

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

Also known as: Platelet function analyzer

Energy drink

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Katherine Newsham, PhD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: February 14, 2017
• Primary Completion: June 9, 2017
• Study Completion: June 20, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)