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| Name | Class |
|---|---|
| The Hershey Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeinated cocoa | Active Comparator | High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle |
|
| Cocoa | Active Comparator | High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle |
|
| Caffeine | Active Comparator | Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle |
|
| Placebo | Placebo Comparator | No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeinated cocoa | Other | 70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline, post 60, post 90, post 120 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre and 90, 120 and 160 minutes post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick O'Connor, PhD | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30602 | United States |
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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January 1, 2019
Open Access
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Caffeinated Cocoa, Cocoa, Caffeine, Placebo | Order: Caffeinated cocoa, cocoa, caffeine, Placebo; 6 participants were randomized to this order. |
| FG001 | Cocoa, Caffeine, Placebo, Caffeinated Cocoa | Order: Cocoa, Caffeine, Placebo, Caffeinated Cocoa; 6 participants were randomize to receive treatment in this order. |
| FG002 | Caffeine, Placebo, Caffeinated Cocoa, Cocoa | Order: Caffeine, Placebo, Caffeinated cocoa, Cocoa; 6 participants were randomized to receive treatment in this order. |
| FG003 | Placebo, Caffeinated Cocoa, Cocoa, Caffeine | Order: Placebo, Caffeinated cocoa, Cocoa, Caffeine; 6 participants were randomized to receive treatment in this order. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Completed Participants | These baseline data represent all participants who completed the trial (n = 23). Data are presented as means and standard deviations where appropriate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Correct responses | Pre and 30, 60 and 120 minutes post intervention |
|
The study personnel monitored participants through study completion, an average of 4 weeks, for adverse events. No adverse events were reported to study personnel.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caffeinated Cocoa | High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 1: High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle |
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Recruitment targeted those reporting low consumption of fruits and vegetables and other foods containing flavonols; not all participants were medication-free; the potential role of sensory aspects of cocoa were not examined.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick J. O'Connor | University of Georgia | 706-542-4382 | poconnor@uga.edu |
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| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Cocoa | Other | 21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener |
|
| Caffeine | Other | 473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener |
|
| Placebo | Other | 473 ml of brewed water, caramel coloring and one packet Truvia sweetener |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Amount of sleep on a typical night in the past month (hrs) | Mean | Standard Deviation | hours |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Post-test 2 |
57-83 minutes post consumption. |
| OG003 | Post-test 3 | 93-119 minutes post consumption. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, post 60, post 90, post 120 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre and 90, 120 and 160 minutes post intervention |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Cocoa | High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle Active comparator 2: High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle | 0 | 23 | 0 | 23 |
| EG002 | Cafeine | Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 4: Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle | 0 | 23 | 0 | 23 |
| EG003 | Placebo | No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle Inactive comparator: No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle | 0 | 23 | 0 | 23 |
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| D014970 |
| Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Bakan Primary Correct - Caffeine |
|
| Bakan Primary Correct - Cocoa |
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| Bakan Primary Correct - Caffeine + Cocoa |
|
| POMS Vigor - Caffeine |
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| POMS Vigor - Cocoa |
|
| POMS Vigor - Caffeinated Cocoa |
|