Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-04-11 @ 4:24 AM
Study NCT ID:
NCT02727920
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2016-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Energy Drinks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061215', 'term': 'Energy Drinks'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2016-03-26', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'attention-memory score', 'timeFrame': '5 hours', 'description': 'Comparing intervention to placebo results on attention-memory score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Energy Drinks']}, 'referencesModule': {'references': [{'pmid': '23452281', 'type': 'BACKGROUND', 'citation': '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': '24176062', 'type': 'BACKGROUND', 'citation': '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': '25560302', 'type': 'BACKGROUND', 'citation': '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': '22324861', 'type': 'BACKGROUND', 'citation': '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': '23722481', 'type': 'BACKGROUND', 'citation': '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': '24644139', 'type': 'BACKGROUND', 'citation': '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': '26378195', 'type': 'BACKGROUND', 'citation': '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': '31990972', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAfter 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.\n\nUpon 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.\n\nThe 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.\n\nWhen 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent in reading English\n* High school graduate as lowest education level\n\nExclusion Criteria:\n\n* Non-smoker\n* No diagnosed/treated cognitive/psychiatric conditions by self-report\n* No diagnosed/treated diabetes, hypoglycemia or thyroid condition by self-report\n* No current use of prescription stimulant medications by self-report\n* No allergies or sensitivities to foods, ingredients or chemicals by self-report, that are contained in the test drink or placebo\n* No diagnosed phenylketonuria'}, 'identificationModule': {'nctId': 'NCT02727920', 'briefTitle': 'Effects of Energy Drinks', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'A Test of the Effects of Energy Drinks', 'orgStudyIdInfo': {'id': '00006831'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'drink containing pyridoxine, folate; B12); taurine, choline, glucuronic acid; tyrosine, phenylalanine\\*, malic acid, and caffeine administered one time.', 'interventionNames': ['Dietary Supplement: Energy drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'description': 'Placebo drink administered one time.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Energy drink', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo drink', 'armGroupLabels': ['Placebo drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bloomberg School of Public Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Lawrence J Cheskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}