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| Name | Class |
|---|---|
| Woodbolt Distribution | UNKNOWN |
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The purpose of this study is to determine how the doses of cognitive-enhancing ingredients such as citicoline and caffeine effect the efficacy of acute energy drink consumption for improving cognitive performance (primary outcome), gaming performance, mood, energy expenditure, and fat oxidation. This study will utilize an In vivo acute response, randomized, double-blind, placebo controlled, cross-over trial study design. Participants will complete consent, complete screening, and then undergo familiarization and complete four experimental study visits. In brief, participants will consume a commercially available energy drink specifically formulated to improve cognitive performance with the standard dose of Cognizin, a reduced dose of Cognizin, a reduced dose of caffeine and Cognizin, or a placebo (water, which will be carbonated, matched for flavor, mouthfeel, etc.), then complete a battery of computer-based cognitive performance test, tasks in a video game (Tetris) to assess video game performance, have their resting metabolism analyzed, and then assessments of mood. Following a 1-week washout period, participants will return and consume one of the four remaining beverages and complete the same tasks. They will participate in four experimental visits, each time consuming a different beverage until they have consumed all beverages and completed all necessary tasks.
Question(s) and Hypotheses (stated in null) Q: Does acute consumption of a new formulations (reduced active ingredients [citicoline and caffeine]) of a commercially available energy drink elicit similar improvements in cognitive performance, mood, energy expenditure and fat oxidation in young adults than the standard, currently marketed dose to formulation?
H1: Acute consumption of the commercially available energy drink with standard dosing will improve cognitive performance compared to the reduced dose beverages and the placebo.
H2: Acute consumption of the commercially available energy drink with standard dosing will improve gaming (Tetris) performance compared to the reduced dose beverages and the placebo.
H3: Acute consumption of the commercially available energy drink with standard dosing will improve mood compared to the reduced dose beverages and the placebo.
H4: Acute consumption of a commercially available energy drink with standard dosing will increase energy expenditure and fat oxidation compared to the reduced dose beverages and the placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Energy Drink | Active Comparator | C4 Smart Energy, 1 can, administered acutely |
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| Reduced Citicoline Energy Drink | Experimental | C4 Smart Energy Reduced Citicoline, 1 can, administered acutely |
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| Reduced Citicoline and Caffeine Energy Drink | Experimental | C4 Smart Energy Reduced Citicoline and Caffeine, 1 can, administered acutely |
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| Placebo | Placebo Comparator | Placebo Drink devoid of active ingredients, 1 can, administered acutely |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy drink consumption | Dietary Supplement | Participants will consume an energy drink (or placebo) and then undergo experimental testing after a 40 minute rest period following drink consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Executive Function | How well a subject recognizes rules, categories, and manages or navigates rapid decision making. Assessed as Shifting Attention Task (SAT) Correct Responses - SAT Errors. | 60 minutes post-drink consumption |
| Resting Fat Oxidation | Resting fat oxidation (g/min) will be quantified from resting, fasted analyses of pulmonary gas exchange. | 50 minutes post-drink consumption |
| Video Game Performance | Performance in the two-dimensional visuospatial game Tetris. Participants will be given four minutes of play time on Marathon mode and instructed to maximize the score (points) displayed on the screen. The total score at the end of play time will be recorded. | 90 minutes post-drink consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Attention | Measure of how well a subject can direct and focus cognitive activity on specific stimuli. Assessed using the 4-part Continuous Performance Test, which requires the subject to respond to the target stimulus "B" but not to any other letter. Stimuli are presented at random and the subject responds by pressing the SPACE BAR. Sustained Attention is then quantified as: (Part 2 Correct Responses + Part 3 Correct Responses + Part 4 Correct Responses) - (Part 2 Incorrect Responses + Part 3 Incorrect Responses + Part 4 Incorrect Responses) |
| Measure | Description | Time Frame |
|---|---|---|
| Tension | Tension will be quantified using the Profile of Mood State Short Form Questionnaire. | 105 minutes post-drink consumption |
| Fatigue | Fatigue will be quantified using the Profile of Mood State Short Form Questionnaire. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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4 condition, randomized cross-over with 3-7 day washout between conditions
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| 60 minutes post-drink consumption |
| Psychomotor Speed | Measure of how well a subject perceives, attends, responds to visual-perceptual information, and performs motor speed and fine motor coordination. To assess psychomotor speed, participants will complete two tests:
Psychomotor Speed is then quantified as a singular outcome using data aggregated from these two tests as: FTT Right Taps Average + FTT Left Taps Average + SDC Correct Responses | 60 minutes post-drink consumption |
| Working Memory | Measure of how well a subject can perceive and attend to symbols using short-term memory processes. Working memory is assessed via completion of the 4-part Continuous Performance Test, which requires the subject to respond to the target stimulus "B" but not to any other letter. Stimuli are presented at random and the subject responds by pressing the SPACE BAR. Working memory is assessed as: Part 4 Correct Responses - Part 4 Incorrect Responses | 60 minutes post-drink consumption |
| Cognitive Flexibility | Measure of how well subject is able to adapt to rapidly changing and increasingly complex set of directions and/or to manipulate the information. Two tests will be used to assess:
Cognitive Flexibility is then quantified as a singular outcome using data aggregated from these two tests as: SAT Correct Responses - SAT Errors - Stroop Commission Errors | 60 minutes post-drink consumption |
| Resting Metabolic Rate | Resting metabolic rate (kcal/min) will be quantified from resting, fasted analyses of pulmonary gas exchange. | 50 minutes post-drink consumption |
| Resting Respiratory Exchange Ratio | Resting respiratory exchange ratio will be quantified from resting, fasted analyses of pulmonary gas exchange. | 50 minutes post-drink consumption |
| Total Mood Disturbance | Total mood disturbance will be quantified using the Profile of Mood State Short Form Questionnaire. | 105-minutes post-drink consumption |
| Vigor-Activity | Vigor will be quantified using the Profile of Mood State Short Form | 105-minutes post-drink consumption |
| Heart rate | Heart rate will be quantified from a standard 3-lead ECG | pre-drink consumption, 40-minutes post-drink consumption, 110 minutes post-drink consumption |
| Blood Pressure | Systolic, diastolic, and pulse pressures (mmHg) will be quantified from brachial | pre-drink consumption, 40 minutes post-drink consumption, 110 minutes post-drink consumption |
| 105 minutes post-drink consumption |
| Anger | Anger will be quantified using the Profile of Mood State Short Form Questionnaire. | 105 minutes post-drink consumption |
| Confusion | Confusion will be quantified using the Profile of Mood State Short Form Questionnaire. | 105 minutes post-drink consumption |
| Friendliness | Friendliness will be quantified using the Profile of Mood State Short Form Questionnaire. | 105 minutes post-drink consumption |