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出境医 / 临床实验 / The Effect of Tablet Size on Cognitive Performance Caffeine (CaC)

The Effect of Tablet Size on Cognitive Performance Caffeine (CaC)

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Placebo Effect Drug: Caffeine Anhydrous with small sucrose pill Other: Placebo - large sucrose pill Drug: Caffeine Anhydrous with large sucrose pill Other: Placebo - small sucrose pill Phase 4

Detailed 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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Single (Participant)
Masking Description: Participants will not be made aware if they have or have not received caffeine to not bias results.
Primary Purpose: Basic Science
Official Title: The Effect of Tablet Size on Cognitive Performance: A Randomized Control Trial Using Caffeine
Actual Study Start Date : October 31, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: 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.
 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 Name: pure caffeine powder
Active Comparator: 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.
 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 Name: pure caffeine powder
Placebo Comparator: 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.
 Other: Placebo - small sucrose pill
sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups
Other Name: sugar pill
Placebo Comparator: 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.
 Other: Placebo - large sucrose pill
sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups
Other Name: sugar pill
Outcome Measures
Primary Outcome Measures :
  1. Stroop Color test [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes ]
    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.

  2. Stroop Word test [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes ]
    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.

  3. Trail Making task A [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes ]
    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.


Secondary Outcome Measures :
  1. Stroop Color-and-Word test [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes ]
    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.

  2. Trail Making task B [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 3 minutes ]
    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.

  3. Rey Auditory Verbal Learning test [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 40 minutes ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80204
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Daniel Hernandez Altamirano Undergraduate honors student
Tracking Information
First Submitted Date  ICMJE October 1, 2018
First Posted Date  ICMJE October 3, 2018
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE October 31, 2018
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Stroop Color test [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes ]
    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.
  • Stroop Word test [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes ]
    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.
  • Trail Making task A [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Stroop Color-and-Word test [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes ]
    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.
  • Trail Making task B [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 3 minutes ]
    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.
  • Rey Auditory Verbal Learning test [ Time Frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 40 minutes ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Tablet Size on Cognitive Performance Caffeine
Official Title  ICMJE The Effect of Tablet Size on Cognitive Performance: A Randomized Control Trial Using Caffeine
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Participant)
Masking Description:
Participants will not be made aware if they have or have not received caffeine to not bias results.
Primary Purpose: Basic Science
Condition  ICMJE Placebo Effect
Intervention  ICMJE
  • 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 Name: pure caffeine powder
  • Other: Placebo - large sucrose pill
    sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups
    Other Name: sugar pill
  • 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 Name: pure caffeine powder
  • Other: Placebo - small sucrose pill
    sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups
    Other Name: sugar pill
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Drug: Caffeine Anhydrous with small sucrose pill
  • Active Comparator: 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.
    Intervention: Drug: Caffeine Anhydrous with large sucrose pill
  • Placebo Comparator: 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.
    Intervention: Other: Placebo - small sucrose pill
  • Placebo Comparator: 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.
    Intervention: Other: Placebo - large sucrose pill
Publications *
  • 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. Review.
  • 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.
  • 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. Review.
  • 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.
  • 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.
  • 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. Epub 2007 Jun 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2018) 		120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03694886
Other Study ID Numbers  ICMJE 18-1086
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Hernandez Altamirano Undergraduate honors student
PRS Account University of Colorado, Denver
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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