NCT02727920

Brief Summary

This study is designed to test the efficacy of energy drinks. This is a double-blinded, crossover, randomized clinical trial, measuring the effect of the test drinks compared with placebo drink in 200 participants aged 18-70 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

March 26, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

April 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

March 26, 2016

Last Update Submit

March 30, 2018

Conditions

Energy Drinks

Outcome Measures

Primary Outcomes (1)

  • attention-memory score

    Comparing intervention to placebo results on attention-memory score

    5 hours

Study Arms (2)

Experimental

EXPERIMENTAL

drink containing pyridoxine, folate; B12); taurine, choline, glucuronic acid; tyrosine, phenylalanine\*, malic acid, and caffeine administered one time.

Dietary Supplement: Energy drink

Placebo drink

PLACEBO COMPARATOR

Placebo drink administered one time.

Other: Placebo

Interventions

Energy drinkDIETARY_SUPPLEMENT
Experimental
PlaceboOTHER

placebo drink

Placebo drink

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in reading English
  • High school graduate as lowest education level

You may not qualify if:

  • Non-smoker
  • No diagnosed/treated cognitive/psychiatric conditions by self-report
  • No diagnosed/treated diabetes, hypoglycemia or thyroid condition by self-report
  • No current use of prescription stimulant medications by self-report
  • No allergies or sensitivities to foods, ingredients or chemicals by self-report, that are contained in the test drink or placebo
  • No diagnosed phenylketonuria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (8)

  • Burrows T, Pursey K, Neve M, Stanwell P. What are the health implications associated with the consumption of energy drinks? A systematic review. Nutr Rev. 2013 Mar;71(3):135-48. doi: 10.1111/nure.12005. Epub 2013 Jan 29.

    PMID: 23452281BACKGROUND

  • Goldfarb M, Tellier C, Thanassoulis G. Review of published cases of adverse cardiovascular events after ingestion of energy drinks. Am J Cardiol. 2014 Jan 1;113(1):168-72. doi: 10.1016/j.amjcard.2013.08.058. Epub 2013 Oct 4.

    PMID: 24176062BACKGROUND

  • Ali F, Rehman H, Babayan Z, Stapleton D, Joshi DD. Energy drinks and their adverse health effects: A systematic review of the current evidence. Postgrad Med. 2015 Apr;127(3):308-22. doi: 10.1080/00325481.2015.1001712. Epub 2015 Jan 6.

    PMID: 25560302BACKGROUND

  • Rath M. Energy drinks: what is all the hype? The dangers of energy drink consumption. J Am Acad Nurse Pract. 2012 Feb;24(2):70-6. doi: 10.1111/j.1745-7599.2011.00689.x. Epub 2012 Jan 31.

    PMID: 22324861BACKGROUND

  • Kurtz AM, Leong J, Anand M, Dargush AE, Shah SA. Effects of caffeinated versus decaffeinated energy shots on blood pressure and heart rate in healthy young volunteers. Pharmacotherapy. 2013 Aug;33(8):779-86. doi: 10.1002/phar.1296. Epub 2013 May 30.

    PMID: 23722481BACKGROUND

  • Phan JK, Shah SA. Effect of caffeinated versus noncaffeinated energy drinks on central blood pressures. Pharmacotherapy. 2014 Jun;34(6):555-60. doi: 10.1002/phar.1419. Epub 2014 Mar 19.

    PMID: 24644139BACKGROUND

  • Shah SA, Nguyen NN, Bhattacharyya M. Energy Implications of Consuming Caffeinated Versus Decaffeinated Energy Drinks. J Pharm Pract. 2015 Oct;28(5):482-3. doi: 10.1177/0897190015585738. No abstract available.

    PMID: 26378195BACKGROUND

  • Garcia-Alvarez A, Cunningham CA, Mui B, Penn L, Spaulding EM, Oakes JM, Divers J, Dickinson SL, Xu X, Cheskin LJ. A randomized, placebo-controlled crossover trial of a decaffeinated energy drink shows no significant acute effect on mental energy. Am J Clin Nutr. 2020 Mar 1;111(3):719-727. doi: 10.1093/ajcn/nqz343.

    PMID: 31990972DERIVED

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Lawrence J Cheskin, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 26, 2016

First Posted

April 5, 2016

Study Start

April 2, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)