Energy DrinksNCT02727920
Effects of Energy Drinks
A study testing Energy drink in people with Energy Drinks, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Drinks
- What is being tested?
- Energy drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent in reading English
- High school graduate as lowest education level
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: A Test of the Effects of Energy Drinks
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.
Read the detailed description
This study is designed to test the efficacy of an energy drink compared to placebo via a double-blind, crossover, randomized clinical trial. Energy levels will be assessed before and after consumption of the test beverages on 2 days separated by a week in 200 participants aged 18-70 years. The study is crossover because the participants will be (randomly) receiving one drink on Test Day 1 and the other drink on Test Day 2.
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
- Energy Drinks
- Being tested
- Energy drink, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy drinkDietary supplement
PlaceboOther
placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | drink containing pyridoxine, folate; B12); taurine, choline, glucuronic acid; tyrosine, phenylalanine*, malic acid, and caffeine administered one time. Receives: Dietary Supplement: Energy drink |
| Placebo drink | Placebo comparator | Placebo drink administered one time. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
attention-memory score
Comparing intervention to placebo results on attention-memory score
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start2 Apr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Energy DrinksStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence J Cheskin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727920
- Sponsor's protocol ID
- 00006831
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23452281Goldfarb 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.
PubMed 24176062Ali 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.
PubMed 25560302Rath 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.
PubMed 22324861Kurtz 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.
PubMed 23722481Phan 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.
PubMed 24644139Shah 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.
PubMed 26378195Garcia-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.
PubMed 31990972
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test of the Effects of Energy Drinks
- ClinicalTrials.gov ID
- NCT02727920
- Acronym / sponsor ID
- 00006831
- Conditions
- Energy Drinks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 2 Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to test the efficacy of an energy drink compared to placebo via a double-blind, crossover, randomized clinical trial. Energy levels will be assessed before and after consumption of the test beverages on 2 days separated by a week in 200 participants aged 18-70 years. The study is crossover because the participants will be (randomly) receiving one drink on Test Day 1 and the other drink on Test Day 2.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Energy drinkdrink containing pyridoxine, folate; B12); taurine, choline, glucuronic acid; tyrosine, phenylalanine*, malic acid, and caffeine administered one time. |
| Placebo drink | Placebo comparator | Other: PlaceboPlacebo drink administered one time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fluent in reading English
- High school graduate as lowest education level
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy drink | Dietary supplement | Experimental |
| Placeboplacebo drink | Other | Placebo drink |
Primary outcome
attention-memory score
Time frame: 5 hours
Comparing intervention to placebo results on attention-memory score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Background: PubMed 23452281Burrows 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.
- Background: PubMed 24176062Goldfarb 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.
- Background: PubMed 25560302Ali 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.
- Background: PubMed 22324861Rath 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.
- Background: PubMed 23722481Kurtz 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.
- Background: PubMed 24644139Phan 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.
- Background: PubMed 26378195Shah 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.
- Derived from this study: PubMed 31990972Garcia-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J Cheskin, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy drink in people with Energy Drinks, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
attention-memory score (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727920, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.