An interventional study of Caffeinated cocoa and Cocoa in Mental Fatigue, sponsored by University of Georgia. Completed at 1 site in United States. Open to participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-25.
Sponsored by University of Georgia · Not applicable, Interventional, and Basic science
The purpose of this study is to determine which substances in cocoa produces changes in mental energy. This is a double blind study. The primary outcome measures are performance on tasks of sustained attention (serial subtract, continuous performance test and Bakan task) at pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile of mood state), and ratings of motivation to perform cognitive tasks. The assigned interventions are the following:
Only one prior study has examined the acute influence of cocoa on mental energy. The purpose of this research is to replicate the previous observations and extend research in four ways: 1) start to determine which substance in cocoa responsible for the effect by including several comparison groups, 2) focus on individuals with average or below average symptoms of mental energy and who are not high consumers of fruits, vegetables and other products containing high amounts of flavonoids in order to learn whether people with low energy accrue a greater benefit, and 3) include additional measures of mental energy plausibly influenced by cocoa to better understand the health consequences of cocoa.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 24 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →University of Georgia is the lead sponsor of 72 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
Other: Caffeinated cocoa
High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
Other: Cocoa
Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
Other: Caffeine
No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle
Other: Placebo
70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener
473 ml of brewed water, caramel coloring and one packet Truvia sweetener
Correct Responses on Serial 7 Subtraction Task
Participants subtract the number 7 from a three digit number and quickly and accurately as possible for 60 seconds. The total number of accurate responses is scored. The higher the score the better performance. The range of scores is from a minimum score of 0 to a theoretical maximum score of 120.
Time frame: Pre and 30, 60 and 120 minutes post intervention
Performance on Bakan Task
Performance on Bakan Task at baseline, post-test 1, post-test 2, and post-test 3 Bakan test presents numbers on a computer screen. Participant presses one button whenever the number 6 appears and a different button whenever three odd and different numbers in a row occurs such as 7 5 9. The number of times the participant does this correctly the better the performance. The scores range from 0 to 10 because the sequence of three odd and different numbers occurs a total of 10 times.
Time frame: baseline, post 60, post 90, post 120
Vigor Symptoms (Profile of Mood State)
Vigor subscale scores from the Profile of Mood States.The higher the score the greater the feelings of energy. The scores range from a minimum of 0 to a maximum of 20.
Time frame: Pre and 90, 120 and 160 minutes post intervention
Potential participants were recruited from (i) large university classes, (ii) announcements on buses, bulletin boards, and electronic listservs, and (iii) through word of mouth. Potential participants were invited to complete screening questionnaires (medical history, diet, mood) administered online using Zoomerang \>http://www.zoomerang.com/\<.
| Milestone | Caffeinated Cocoa, Cocoa, Caffeine, Placebo | Cocoa, Caffeine, Placebo, Caffeinated Cocoa | Caffeine, Placebo, Caffeinated Cocoa, Cocoa | Placebo, Caffeinated Cocoa, Cocoa, Caffeine |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 |
| Completed | 6 | 6 | 6 | 5 |
| Not completed | 0 | 0 | 0 | 1 |
Participants subtract the number 7 from a three digit number and quickly and accurately as possible for 60 seconds. The total number of accurate responses is scored. The higher the score the better performance. The range of scores is from a minimum score of 0 to a theoretical maximum score of 120.
| Correct responses | Pre-test | Post-test 1 | Post-test 2 | Post-test 3 |
|---|---|---|---|---|
| Subtract 7 Correct - Placebo | 40.91 ± 5.56 | 42.57 ± 3.51 | 43.04 ± 2.31 | 42.13 ± 3.67 |
| Subtract 7 Correct - Caffeine | 41.83 ± 3.56 | 41.35 ± 3.73 | 43.22 ± 2.92 | 42.74 ± 3.03 |
| Subtract 7 Correct - Cocoa | 42.57 ± 2.52 | 42.61 ± 3.86 | 42.78 ± 3.06 | 42.61 ± 3.81 |
| Subtract 7 Correct - Caffeine + Cocoa | 42.17 ± 3.24 | 42.26 ± 2.47 | 42.96 ± 2.33 | 43.14 ± 2.88 |
Performance on Bakan Task at baseline, post-test 1, post-test 2, and post-test 3 Bakan test presents numbers on a computer screen. Participant presses one button whenever the number 6 appears and a different button whenever three odd and different numbers in a row occurs such as 7 5 9. The number of times the participant does this correctly the better the performance. The scores range from 0 to 10 because the sequence of three odd and different numbers occurs a total of 10 times.
| units on a scale | Pre-test | Post-test 1 | Post-test 2 | Post-test 3 |
|---|---|---|---|---|
| Bakan Primary Correct - Placebo | 6.35 ± 1.53 | 6.00 ± 1.57 | 5.96 ± 2.01 | 6.09 ± 1.95 |
| Bakan Primary Correct - Caffeine | 6.35 ± 1.50 | 6.57 ± 1.78 | 6.87 ± 1.39 | 6.13 ± 1.36 |
| Bakan Primary Correct - Cocoa | 6.43 ± 1.59 | 6.52 ± 1.44 | 6.30 ± 1.11 | 5.78 ± 1.70 |
| Bakan Primary Correct - Caffeine + Cocoa | 5.83 ± 1.59 | 6.13 ± 1.77 | 6.35 ± 1.77 | 6.61 ± 1.47 |
Vigor subscale scores from the Profile of Mood States.The higher the score the greater the feelings of energy. The scores range from a minimum of 0 to a maximum of 20.
| units on a scale | Pre-test | Post-test 1 | Post-test 2 | Post-test 3 |
|---|---|---|---|---|
| POMS Vigor - Placebo | 3.78 ± 4.36 | 3.57 ± 4.00 | 3.52 ± 3.44 | 3.65 ± 3.68 |
| POMS Vigor - Caffeine | 3.91 ± 3.66 | 3.91 ± 3.99 | 4.00 ± 3.92 | 4.26 ± 3.29 |
| POMS Vigor - Cocoa | 3.65 ± 4.01 | 3.74 ± 3.45 | 4.00 ± 3.84 | 3.70 ± 3.30 |
| POMS Vigor - Caffeinated Cocoa | 4.09 ± 4.43 | 4.48 ± 4.28 | 4.04 ± 4.03 | 4.17 ± 3.87 |
Collected over The study personnel monitored participants through study completion, an average of 4 weeks, for adverse events. No adverse events were reported to study personnel.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Caffeinated Cocoa | — | 0/23 (0%) | 0/23 (0%) |
| Cocoa | — | 0/23 (0%) | 0/23 (0%) |
| Cafeine | — | 0/23 (0%) | 0/23 (0%) |
| Placebo | — | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | All Completed Participants |
|---|---|
| Mean | 20 ± 2 |
| Sex: Female, Male(Participants) | All Completed Participants |
|---|---|
| Female | 17 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | All Completed Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 15 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Completed Participants |
|---|---|
| United States | 23 |
| Amount of sleep on a typical night in the past month (hrs)(hours) | All Completed Participants |
|---|---|
| Mean | 7.4 ± 1.1 |
| Height(cm) | All Completed Participants |
|---|---|
| Mean | 168.28 ± 1.19 |
| Weight(kg) | All Completed Participants |
|---|---|
| Mean | 67.05 ± 14.87 |
Plan to share: Yes — IPD will be kept securely at the University of Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu).
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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