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Trial record 16 of 33690 for:    Placebo AND placebo effect

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

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ClinicalTrials.gov Identifier: NCT03694886
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
Drug Information available for: Sucrose

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694886


Locations
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United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80204
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Daniel Hernandez Altamirano Undergraduate honors student
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Informed Consent Form  [PDF] September 20, 2018


Publications:
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.
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

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03694886     History of Changes
Other Study ID Numbers: 18-1086
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents