The Effect of Tablet Size on Cognitive Performance Caffeine

NCT03694886 | Completed Phase 4

• 1 other identifier: 18-1086
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Placebo Effect

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Stroop Color-and-Word test

  Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes

• Trail Making task B

  Within 90 minutes of receiving informed consent. Actual task time: approximately 3 minutes

• Rey Auditory Verbal Learning test

  Within 90 minutes of receiving informed consent. Actual task time: approximately 40 minutes

Study Arms (4)

Caffeine with small sucrose pill

ACTIVE COMPARATOR

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 with large sucrose pill

ACTIVE COMPARATOR

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

No caffeine with small sucrose pill

PLACEBO COMPARATOR

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

No caffeine with large sucrose pill

PLACEBO COMPARATOR

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

Interventions

Caffeine Anhydrous with small sucrose pill DRUG

caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 1 mm sucrose pillule

Also known as: pure caffeine powder

Caffeine with small sucrose pill

Placebo - large sucrose pill OTHER

sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups

Also known as: sugar pill

No caffeine with large sucrose pill

Caffeine Anhydrous with large sucrose pill DRUG

caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 5 mm sucrose pillule

Also known as: pure caffeine powder

Caffeine with large sucrose pill

Placebo - small sucrose pill OTHER

sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups

Also known as: sugar pill

No caffeine with small sucrose pill

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Denver, Colorado, 80204, United States

Location

Related Publications (19)

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  PMID: 14589618 BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Smith SR, Servesco AM, Edwards JW, Rahban R, Barazani S, Nowinski LA, Little JA, Blazer AL, Green JG. Exploring the validity of the comprehensive trail making test. Clin Neuropsychol. 2008 May;22(3):507-18. doi: 10.1080/13854040701399269. Epub 2007 Jun 18.

  PMID: 17853128 BACKGROUND

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Daniel Hernandez Altamirano

  Undergraduate honors student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be made aware if they have or have not received caffeine to not bias results.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: October 31, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)