The Effect of Tablet Size on Cognitive Performance Caffeine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Placebo Effect

Intervention / Treatment
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* Drug: Caffeine Anhydrous with small sucrose pill
* Other: Placebo - large sucrose pill
* Drug: Caffeine Anhydrous with large sucrose pill
* Other: Placebo - small sucrose pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caffeine with small sucrose pill<br>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<br>* caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 1 mm sucrose pillule<br>* Other names: pure caffeine powder;|
| Active Comparator: Caffeine with large sucrose pill<br>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<br>* caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 5 mm sucrose pillule<br>* Other names: pure caffeine powder;|
| Placebo Comparator: No caffeine with small sucrose pill<br>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<br>* sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups<br>* Other names: sugar pill;|
| Placebo Comparator: No caffeine with large sucrose pill<br>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<br>* sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |