Effects of a Cocoa Shot on the Human Brain

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Cocoa Shot on the Human Brain

Conditions
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Caffeine, Flavonoids

Intervention / Treatment
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* Dietary Supplement: High Caffeine
* Dietary Supplement: Low caffeine
* Dietary Supplement: High theobromine
* Dietary Supplement: low theobromine
* Dietary Supplement: No theobromine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consume 200-600 mg caffeine daily Willing and capable of signing the informed consent Willing to attend 4 testing sessions that will take 4-6 hours each AND will be at least 7 days apart Willing to abstain from caffeine for 24 hours before each testing session Willing to and able to have MRIs Exclusion Criteria: As determined from the medical screening session active neurological dysfunction (such as a major Axis I psychopathology, Alzheimer's disease, Parkinson's disease, prior history of stroke, epilepsy, or serious central nervous system (CNS) trauma) attention deficit hyperactivity disorder (ADHD) migraines hypertension diabetes peripheral vascular disease taking vasoactive medications (such as anti-hypertensive medications) depression that has not been on a stable medical treatment for at least 4 weeks 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low theobromine & low caffeine<br>Drink 1 | Dietary Supplement: Low caffeine<br> <br> Dietary Supplement: low theobromine<br> <br> |
| Experimental: low theobromine & high caffeine<br>Drink 2 | Dietary Supplement: High Caffeine<br> <br> Dietary Supplement: low theobromine<br> <br> |
| Experimental: high theobromine & low caffeine<br>Drink 3 | Dietary Supplement: Low caffeine<br> <br> Dietary Supplement: High theobromine<br> <br> |
| Active Comparator: no theobromine & high caffeine<br>Drink 4 | Dietary Supplement: High Caffeine<br> <br> Dietary Supplement: No theobromine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caffeine, Flavonoids, MRI, Brain blood flow, Cognition, Perfusion, Resting functional magnetic resonance imaging (fMRI)