Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
228 participants
INTERVENTIONAL
2016-04-02
2016-07-31
Brief Summary
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Detailed Description
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After signing written informed consent, participants will be fed a light lunch, and their pulse, weight and height measured. A baseline battery of computer-based tests to assess energy levels will be conducted. These computer-based measures will take \~40 minutes to complete and will include: a) a long-term memory test b) a Profile of Mood States (POMS2) brief form; c) Rapid Visual Information Processing (RVIP) test, d) The N-Back Task; d) Reaction time online test; f) the Flanker Task. Participants will then be asked to fill out a baseline survey (30 min), with questions about current health-related behaviors, specifically questions about physical activity and diet.
Upon completing the baseline battery (survey administered at test session 1 only), participants will be randomly administered the energy drink or the placebo to consume while observed. Subsequently, the battery of computer-based tests to assess energy levels will be re-administered 30 minutes, 2.5 hours and 5 hours after consumption of the test drink.
The study intervention will be double-blinded: participants will be blinded to whether they are receiving the active or the placebo drink, and study team members will also not be aware of the assignment.
When the study ends, full compensation will be given if the intervention is fully completed; if the intervention is not fully completed, partial compensation will be given.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Experimental
drink containing pyridoxine, folate; B12); taurine, choline, glucuronic acid; tyrosine, phenylalanine\*, malic acid, and caffeine administered one time.
Energy drink
Placebo drink
Placebo drink administered one time.
Placebo
placebo drink
Interventions
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Energy drink
Placebo
placebo drink
Eligibility Criteria
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Inclusion Criteria
* High school graduate as lowest education level
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Lawrence J Cheskin, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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00006831
Identifier Type: -
Identifier Source: org_study_id
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