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.
COMPLETED
NA
205 participants
30 minutes post pill consumption
2017-07-12
Participant Flow
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
| 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 consumptionPopulation: 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
| 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 consumptionPopulation: 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
| 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 consumptionPopulation: 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
| 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 consumptionPopulation: 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
| 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
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place