The Effect of Tablet Size on Cognitive Performance Caffeine
NCT ID: NCT03694886
Last Updated: 2019-04-17
Study Results
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Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2018-10-31
2019-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1\) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule.
BASIC_SCIENCE
SINGLE
Study Groups
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Caffeine with small sucrose pill
Participants will be given one dose of 90 milligrams caffeine anhydrous dissolved in 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered.
Caffeine Anhydrous with small sucrose pill
caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 1 mm sucrose pillule
Caffeine with large sucrose pill
Participants will be given one dose of 90 milligrams caffeine anhydrous dissolved in 8 ounces of water and a 5 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered.
Caffeine Anhydrous with large sucrose pill
caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 5 mm sucrose pillule
No caffeine with small sucrose pill
Participants will be given 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered.
Placebo - small sucrose pill
sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups
No caffeine with large sucrose pill
Participants will be given 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered.
Placebo - large sucrose pill
sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups
Interventions
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Caffeine Anhydrous with small sucrose pill
caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 1 mm sucrose pillule
Placebo - large sucrose pill
sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups
Caffeine Anhydrous with large sucrose pill
caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 5 mm sucrose pillule
Placebo - small sucrose pill
sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to see color
* No uncontrolled high blood pressure
* No allergies to caffeine or sucrose
* No history of heart disease
* No untreated anxiety or depression
* Non-pregnant
* No caffeine consumed the day of participation
Exclusion Criteria
* Uncontrolled high blood pressure
* Color-blindness
* Allergies to caffeine and/or sucrose
* History of heart disease
* Untreated anxiety or depression
* Pregnant
* Consumed caffeine on the day of participation
18 Years
40 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Daniel Hernandez Altamirano
Role: PRINCIPAL_INVESTIGATOR
Undergraduate honors student
Locations
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University of Colorado Denver
Denver, Colorado, United States
Countries
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References
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Beaumont R, Cordery P, Funnell M, Mears S, James L, Watson P. Chronic ingestion of a low dose of caffeine induces tolerance to the performance benefits of caffeine. J Sports Sci. 2017 Oct;35(19):1920-1927. doi: 10.1080/02640414.2016.1241421. Epub 2016 Oct 20.
Buckalew LW, Coffield KE. An investigation of drug expectancy as a function of capsule color and size and preparation form. J Clin Psychopharmacol. 1982 Aug;2(4):245-8.
Champlin SE, Pasch KE, Perry CL. Is the Consumption of Energy Drinks Associated With Academic Achievement Among College Students? J Prim Prev. 2016 Aug;37(4):345-59. doi: 10.1007/s10935-016-0437-4.
Cole JS. A survey of college-bound high school graduates regarding circadian preference, caffeine use, and academic performance. Sleep Breath. 2015 Mar;19(1):123-7. doi: 10.1007/s11325-014-0976-y. Epub 2014 May 1.
Czerniak E, Davidson M. Placebo, a historical perspective. Eur Neuropsychopharmacol. 2012 Nov;22(11):770-4. doi: 10.1016/j.euroneuro.2012.04.003. Epub 2012 May 18.
Franzen MD, Tishelman AC, Sharp BH, Friedman AG. An investigation of the test-retest reliability of the Stroop Color-Word Test across two intervals. Arch Clin Neuropsychol. 1987;2(3):265-72.
Geuter S, Koban L, Wager TD. The Cognitive Neuroscience of Placebo Effects: Concepts, Predictions, and Physiology. Annu Rev Neurosci. 2017 Jul 25;40:167-188. doi: 10.1146/annurev-neuro-072116-031132. Epub 2017 Apr 7.
Hammond DC. A review of the history of hypnosis through the late 19th century. Am J Clin Hypn. 2013 Oct;56(2):174-91. doi: 10.1080/00029157.2013.826172.
Ibrahim IR, Ibrahim MI, Al-Haddad MS. The influence of consumers' preferences and perceptions of oral solid dosage forms on their treatment. Int J Clin Pharm. 2012 Oct;34(5):728-32. doi: 10.1007/s11096-012-9667-6. Epub 2012 Jun 29.
Kinirons MT, O'Mahony MS. Drug metabolism and ageing. Br J Clin Pharmacol. 2004 May;57(5):540-4. doi: 10.1111/j.1365-2125.2004.02096.x.
Lessard, M. D. (1993). Study of the Velten Mood Induction Procedure and the measurement of mood. Graduate Student Theses, Dissertations, & Professional Papers. 4973. https://scholarworks.umt.edu/etd/4973
Magalhaes, S. d. S., Malloy-Diniz, L. F., & Hamdan, A. C. (2012). Validity convergent and reliability test-retest of the rey auditory verbal learning test. Clinical Neuropsychiatry: Journal of Treatments Evaluation, 9(3), 129.
Nehlig A, Daval JL, Debry G. Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic and psychostimulant effects. Brain Res Brain Res Rev. 1992 May-Aug;17(2):139-70. doi: 10.1016/0165-0173(92)90012-b.
Overgaard AB, Hojsted J, Hansen R, Moller-Sonnergaard J, Christrup LL. Patients' evaluation of shape, size and colour of solid dosage forms. Pharm World Sci. 2001 Oct;23(5):185-8. doi: 10.1023/a:1012050931018.
Pasman WJ, Boessen R, Donner Y, Clabbers N, Boorsma A. Effect of Caffeine on Attention and Alertness Measured in a Home-Setting, Using Web-Based Cognition Tests. JMIR Res Protoc. 2017 Sep 7;6(9):e169. doi: 10.2196/resprot.6727.
Pettit ML, DeBarr KA. Perceived stress, energy drink consumption, and academic performance among college students. J Am Coll Health. 2011;59(5):335-41. doi: 10.1080/07448481.2010.510163.
Ross, S., & Buckalew, L. W. (1979). On the agentry of placebos. American Psychologist, 34(3), 277-278. 10.1037/0003-066X.34.3.277
Scientific Opinion on the substantiation of health claims related to caffeine and increased fat oxidation leading to a reduction in body fat mass (ID 735, 1484), increased energy expenditure leading to a reduction in body weight (ID 1487), increased alert. (2011). EFSA Journal, 9(4), 2054. doi:10.2903/j.efsa.2011.2054
Smith SR, Servesco AM, Edwards JW, Rahban R, Barazani S, Nowinski LA, Little JA, Blazer AL, Green JG. Exploring the validity of the comprehensive trail making test. Clin Neuropsychol. 2008 May;22(3):507-18. doi: 10.1080/13854040701399269. Epub 2007 Jun 18.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18-1086
Identifier Type: -
Identifier Source: org_study_id
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