The Effect of Tablet Size on Cognitive Performance Caffeine

Placebo Effect Clinical Trial

— CaC  

Official title:

The Effect of Tablet Size on Cognitive Performance: A Randomized Control Trial Using Caffeine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694886
• Other study ID #: 18-1086
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine. Participants will be randomly assigned to one of four groups: 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.

Description:

Background: A capsule's physical design (e.g. shape, size, and color) affects individuals' perception of drug efficacy; that is, how well a drug is likely to work. The goal of this study is to assess the effects tablet size may have on participant's performance on cognitive testing since research has found differences between preparation methods. Method: 120 participants will be randomly assigned to one of four groups: 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. Participants will consume the designated placebo tablet with water (caffeinated or non-caffeinated); then, participants will provide weekly caffeine intake and complete the neutral portion of Velten's Mood Induction Procedure until 30 minutes have passed to allow for caffeine activation. Participants will complete the Stroop test, Trial Making Tests A and B, and the Rey Auditory Verbal Learning Test. Previous literature, as far as the author knows, relied on evaluating drug efficacy based on appearance alone. This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Fluent in written and spoken English

• 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:

• Not fluent in written and/or spoken English

• 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

Related Conditions & MeSH terms

• Placebo Effect

Intervention

Drug:
• 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

Other:
• Placebo - large sucrose pill
sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups

Drug:
• 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

Other:
• Placebo - small sucrose pill
sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups

Locations

Country	Name	City	State
United States	University of Colorado Denver	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Hammond DC. A review of the history of hypnosis through the late 19th century. Am J Clin Hypn. 2013 Oct;56(2):174-91. Review. — View Citation

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. — View Citation

Kinirons MT, O'Mahony MS. Drug metabolism and ageing. Br J Clin Pharmacol. 2004 May;57(5):540-4. Review. — View Citation

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. Review. — View Citation

Overgaard AB, Højsted J, Hansen R, Møller-Sonnergaard J, Christrup LL. Patients' evaluation of shape, size and colour of solid dosage forms. Pharm World Sci. 2001 Oct;23(5):185-8. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Jun 18. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroop Color test	Measures processing speed. 100-item, time-trial task where participants read the color of printed items on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time.	Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes
Primary	Stroop Word test	Measures processing speed. 100-item, time-trial task where participants read color names printed on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time.	Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes
Primary	Trail Making task A	Measures processing speed. 25 item, time-trial task where participants must connect numbers in order as quickly as possible. Scores are measured by the amount of time (in seconds) for participants to complete the task.	Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes
Secondary	Stroop Color-and-Word test	Measures processing speed. 100-item, time-trial task where participants must read the color of the ink instead of color names printed on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time.	Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes
Secondary	Trail Making task B	Measures processing speed. 25 item, time-trial task where participants must connect numbers and letters in order (e.g. 1-A-2-B, etc.) as quickly as possible. Scores are measured by the amount of time (in seconds) for participants to complete the task.	Within 90 minutes of receiving informed consent. Actual task time: approximately 3 minutes
Secondary	Rey Auditory Verbal Learning test	Measures memory. 30-item, 2 section task where participants are read 15 words and asked to recall as many words as possible in the first section. A second set of 15 words is then introduced and participants recall those. The second section consists of revisiting the original set of words and recalling as many of those. Scores are measured by the total words remembered in section one, and another score for the total intrusions from the second list into the recall of section two.	Within 90 minutes of receiving informed consent. Actual task time: approximately 40 minutes