Clinical trial NCT03694886: The Effect of Tablet Size on Cognitive Performance Caffeine
Official title: The Effect of Tablet Size on Cognitive Performance: A Randomized Control Trial Using Caffeine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Placebo Effect
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Stroop Color test
timeFrame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes
measure: Stroop Word test
timeFrame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes
measure: Trail Making task A
timeFrame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes
Secondary outcomes:
measure: Stroop Color-and-Word test
timeFrame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes
measure: Trail Making task B
timeFrame: Within 90 minutes of receiving informed consent. Actual task time: approximately 3 minutes
measure: Rey Auditory Verbal Learning test
timeFrame: Within 90 minutes of receiving informed consent. Actual task time: approximately 40 minutes
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: Undergraduate honors student
name: Daniel Hernandez Altamirano
role: PRINCIPAL_INVESTIGATOR
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