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| Name | Class |
|---|---|
| The Hershey Company | INDUSTRY |
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The Hershey Company is interested in investigating the effects of various chocolate beverages on brain physiology and cognitive function. The main substances in the drinks that are known to influence the brain are caffeine (and related chemicals such as theobromine) and flavonoids. Flavonoids are chemical found in plants and are most commonly associated with antioxidant activity. Caffeine, chemicals related to caffeine, and flavonoids are all naturally occurring and all potentially alter brain physiology. This study will evaluate changes in brain blood flow and cognition following the consumption of drinks with various combinations of the Primary Ingredients. Caffeine is likely to have peak effects within 1-hour of ingesting the chocolate while the flavonoids are likely to have peak effects 3-4 hours after ingestion. The study proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an attempt to understand the differential effects of these compounds in chocolate drinks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low theobromine & low caffeine | Experimental | Drink 1 |
|
| low theobromine & high caffeine | Experimental | Drink 2 |
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| high theobromine & low caffeine | Experimental | Drink 3 |
|
| no theobromine & high caffeine | Active Comparator | Drink 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Caffeine | Dietary Supplement |
| ||
| Low caffeine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Working Memory (% correct) | N-Back Task | before, 1 hour and 3 hours post beverage |
| Change in Response Time (milliseconds) | Simple Response Time Task | before, 1 hour and 3 hours post beverage |
| Change in Short Term Memory (# correct) | Hopkins Verbal Learning Task (HVLT) | before, 1 hour and 3 hours post beverage |
| Change in Mood (change in Likert scale score) | Profile of Mood Status(POMS) | before, 1 hour and 3 hours post beverage |
| Change in Attention (% accuracy) | Eriksen Flanker Task | before, 1 hour and 3 hours post beverage |
| Change in Executive Function (# correct) | Stroop Task | before, 1 hour and 3 hours post beverage |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Blood Flow (ml/g/min) | Non-invasive brain perfusion measured with arterial spin labeling magnetic resonance imaging | 1 hour and 3 hours post beverage |
| % Change in Heart Rate (beats/minute) |
| Measure | Description | Time Frame |
|---|---|---|
| % Change in Brain Connectivity (network degree) | Measures of functional brain connectivity based on resting-state functional magnetic resonance imaging. | 1 hour and 3 hours post beverage |
Inclusion Criteria:
Exclusion Criteria:
As determined from the medical screening session
Pregnancy
Color blindness
Allergy to chocolate, peanuts, tree nuts, egg, soy, mike, wheat
Individuals who are or potentially may be cognitively or psychologically impaired, or who otherwise have a limited capacity to provide consent
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| Name | Affiliation | Role |
|---|---|---|
| Paul J. Laurienti, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Dietary Supplement |
|
| High theobromine | Dietary Supplement |
|
| low theobromine | Dietary Supplement |
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| No theobromine | Dietary Supplement |
|
pulse
| before, 1 hour and 3 hours post beverage |
| % Change in Respiration (breaths/minute) | before, 1 hour and 3 hours post beverage |
| % Change in Blood Pressure (mmHg) | before, 1 hour and 3 hours post beverage |