NCT03324256

Brief Summary

The purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

October 20, 2017

Last Update Submit

May 16, 2019

Conditions

Vascular Function

Keywords

Energy drink consumption

Outcome Measures

Primary Outcomes (1)

  • Change in endothelial function

    Brachial artery flow-mediated dilation

    Before and 1 and 2 hrs following consumption of drink and gum

Secondary Outcomes (6)

  • Change in arterial stiffness

    Before and 1 and 2 hrs following consumption of drink and gum

  • Change in wave reflection

    Before and 1 and 2 hrs following consumption of drink and gum

  • Change in peripheral and central blood pressures

    Before and 1 and 2 hrs following consumption of drink and gum

  • Change in thrombosis and platelet function

    Before and 1 and 2 hrs following consumption of drink and gum

  • Change in circulating factors related to vascular function

    Before and 1 and 2 hrs following consumption of drink and gum

  • +1 more secondary outcomes

Study Arms (5)

Energy drink and placebo gum

ACTIVE COMPARATOR

Commercially-available energy drink (16oz) + 2 pieces of placebo gum

Other: energy drinkOther: placebo gum

Caffeinated drink and placebo gum

ACTIVE COMPARATOR

Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum

Other: caffeinated drinkOther: placebo gum

Control drink and energy gum

ACTIVE COMPARATOR

Control drink (16oz) + 2 pieces of energy gum

Other: Energy gumOther: Control drink

Control drink and placebo gum

PLACEBO COMPARATOR

Control drink (16oz) + 2 pieces of placebo gum

Other: placebo gumOther: Control drink

Energy drink and total sleep deprivation

ACTIVE COMPARATOR

Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation

Other: energy drinkOther: placebo gumOther: Total sleep deprivation

Interventions

energy drinkOTHER

16 oz cold commercially-available energy drink

Energy drink and placebo gumEnergy drink and total sleep deprivation
caffeinated drinkOTHER

16oz cold commercially-available caffeinated drink

Caffeinated drink and placebo gum
Energy gumOTHER

2 pieces of commercially-available energy gum

Control drink and energy gum
placebo gumOTHER

2 pieces of commercially-available placebo gum

Caffeinated drink and placebo gumControl drink and placebo gumEnergy drink and placebo gumEnergy drink and total sleep deprivation
Control drinkOTHER

16oz cold control drink

Control drink and energy gumControl drink and placebo gum
Total sleep deprivationOTHER

24-hour total sleep deprivation prior to consumption of energy drink and placebo gum

Energy drink and total sleep deprivation

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being Male
  • years of age
  • No indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease)
  • BMI ≤ 30 kg/m\^2 and blood pressure ≤ 140/90 mmHg
  • Consumption of \<400mg of caffeine/day
  • Prior history of consumption of energy drinks

You may not qualify if:

  • Being female
  • Age \<18 or \>30 years
  • BMI\> 30 kg/m\^2 and blood pressure \> 140/90 mmHg
  • Use of medication that may affect vascular measures
  • Use of tobacco products including smoking
  • Vegan or vegetarian diet
  • Being energy drink or caffeine naïve or consumption of \>400 mg of caffeine/day
  • Consumption of \>1 energy drinks per month
  • Being a shift worker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Demetra Christou, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

October 27, 2017

Study Start

January 12, 2018

Primary Completion

May 16, 2019

Study Completion

May 16, 2019

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

US(1)