Trial Outcomes & Findings for Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT (NCT NCT02461693)

NCT ID: NCT02461693

Last Updated: 2017-07-12

Results Overview

Profile of Mood States (POMS-2)- "Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling "right now" on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable." - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

205 participants

Primary outcome timeframe

30 minutes post pill consumption

Results posted on

2017-07-12

Participant Flow

Participant milestones

Participant milestones
Measure
Caffeine
One-time treatment with 200mg caffeine pill Caffeine: 200mg delivered as pill; one-time dose
Placebo
One-time treatment with lactose-based placebo pill Placebo
Overall Study
STARTED
103
102
Overall Study
COMPLETED
103
102
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Caffeine
n=100 Participants
One-time treatment with 200mg caffeine pill Caffeine: 200mg delivered as pill; one-time dose
Placebo
n=100 Participants
One-time treatment with lactose-based placebo pill Placebo
Total
n=200 Participants
Total of all reporting groups
Age, Continuous
33.83 years
STANDARD_DEVIATION 14.02 • n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
29.75 years
STANDARD_DEVIATION 11.39 • n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
31.79 years
STANDARD_DEVIATION 12.91 • n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Sex: Female, Male
Female
62 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
61 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
123 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Sex: Female, Male
Male
38 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
39 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
77 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
7 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
8 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Ethnicity (NIH/OMB)
Not Hispanic or Latino
84 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
75 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
159 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Ethnicity (NIH/OMB)
Unknown or Not Reported
15 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
18 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
33 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
0 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
0 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Race (NIH/OMB)
Asian
16 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
12 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
28 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
0 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
0 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Race (NIH/OMB)
Black or African American
39 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
50 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
89 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Race (NIH/OMB)
White
39 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
30 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
69 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
0 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
0 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=99 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
8 Participants
n=107 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis
14 Participants
n=206 Participants • 5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis

PRIMARY outcome

Timeframe: 30 minutes post pill consumption

Population: Results are of raw data as presented in our publication

Profile of Mood States (POMS-2)- "Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling "right now" on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable." - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score.

Outcome measures

Outcome measures
Measure
Caffeine
n=100 Participants
One-time treatment with 200mg caffeine pill Caffeine: 200mg delivered as pill; one-time dose
Placebo
n=100 Participants
One-time treatment with lactose-based placebo pill Placebo
Mood State Score on POMS-2 Test
Total Mood Displacement
2.63 units on a scale
Standard Error 1.98
14.08 units on a scale
Standard Error 2.86
Mood State Score on POMS-2 Test
Anger-Hostility
2.19 units on a scale
Standard Error 0.38
2.54 units on a scale
Standard Error 0.46
Mood State Score on POMS-2 Test
Confusion-Bewilderment
6.23 units on a scale
Standard Error 0.48
7.00 units on a scale
Standard Error 0.53
Mood State Score on POMS-2 Test
Depression-Dejection
1.87 units on a scale
Standard Error 0.35
3.15 units on a scale
Standard Error 0.61
Mood State Score on POMS-2 Test
Fatigue-Inertia
4.44 units on a scale
Standard Error 0.49
6.65 units on a scale
Standard Error 0.68
Mood State Score on POMS-2 Test
Friendliness
13.47 units on a scale
Standard Error 0.47
12.97 units on a scale
Standard Error 0.44
Mood State Score on POMS-2 Test
Tension-Anxiety
5.53 units on a scale
Standard Error 0.52
5.81 units on a scale
Standard Error 0.52
Mood State Score on POMS-2 Test
Vigor-Activity
16.35 units on a scale
Standard Error 0.73
13.13 units on a scale
Standard Error 0.69

PRIMARY outcome

Timeframe: 45 to 105 minutes post pill consumption

Population: One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.

Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication

Outcome measures

Outcome measures
Measure
Caffeine
n=99 Participants
One-time treatment with 200mg caffeine pill Caffeine: 200mg delivered as pill; one-time dose
Placebo
n=100 Participants
One-time treatment with lactose-based placebo pill Placebo
Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)
0.932 Proportion correct
Standard Error 0.014
0.888 Proportion correct
Standard Error 0.017

PRIMARY outcome

Timeframe: 45 to 105 minutes post pill consumption

Population: One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.

Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication

Outcome measures

Outcome measures
Measure
Caffeine
n=99 Participants
One-time treatment with 200mg caffeine pill Caffeine: 200mg delivered as pill; one-time dose
Placebo
n=100 Participants
One-time treatment with lactose-based placebo pill Placebo
Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits
Number correct (out of 60)
55.9 counts
Standard Error 0.85
53.3 counts
Standard Error 1.00
Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits
Number of False Alarm Hits
4.21 counts
Standard Error 0.67
5.80 counts
Standard Error 1.01

PRIMARY outcome

Timeframe: 45 to 105 minutes post pill consumption

Population: One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.

Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication

Outcome measures

Outcome measures
Measure
Caffeine
n=99 Participants
One-time treatment with 200mg caffeine pill Caffeine: 200mg delivered as pill; one-time dose
Placebo
n=100 Participants
One-time treatment with lactose-based placebo pill Placebo
Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit
0.74 seconds
Standard Error 0.03
0.88 seconds
Standard Error 0.03

Adverse Events

Caffeine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Allison, PI

University of Alabama at Birmingham

Phone: 205-975-9169

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place