Placebo Effect Clinical Trial
— CaCOfficial title:
The Effect of Tablet Size on Cognitive Performance: A Randomized Control Trial Using Caffeine
Verified date | April 2019 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
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* Note: There are 19 references in all — Click here to view all references
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 |
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