The Effect of Tablet Size on Cognitive Performance Caffeine

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Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 5, 2018

Estimated Primary Completion Date

February 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Current Secondary Outcome Measures ^ICMJE

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.

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

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: Interventional
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

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: 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

Study Arms

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.
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.
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.
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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

February 2019

Estimated Primary Completion Date

February 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

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Daniel Hernandez Altamirano Undergraduate honors student

PRS Account

Verification Date

October 2018

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

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