Effects of a Cocoa Shot on the Human Brain 2

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. Caffeine and chemicals related to caffeine 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. 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 2

Conditions
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Caffeine

Intervention / Treatment
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* Dietary Supplement: no caffeine
* Dietary Supplement: high caffeine
* Dietary Supplement: no theobromine
* Dietary Supplement: low theobromine
* Dietary Supplement: high theobromine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consume 200-500 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 10 days apart Willing to abstain from caffeine for 16 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 Allergy to chocolate, peanuts, tree nuts, egg, soy, milk, wheat Color blindness 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: 55 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 |
| --- | --- |
| Placebo Comparator: no caffeine & no theobromine<br>Drink 1 | Dietary Supplement: no caffeine<br> <br> Dietary Supplement: no theobromine<br> <br> |
| Experimental: no caffeine & low theobromine<br>Drink 2 | Dietary Supplement: no caffeine<br> <br> Dietary Supplement: low theobromine<br> <br> |
| Experimental: no caffeine & high theobromine<br>Drink 3 | Dietary Supplement: no caffeine<br> <br> Dietary Supplement: high theobromine<br> <br> |
| Experimental: high caffeine & no theobromine<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 | Baseline, 1.5 hour and 3.5 hours post beverage | 
| Change in Response Time (milliseconds) | Choice ResponseTime Task | Baseline, 1.5 hour and 3.5 hours post beverage | 
| Change in Short Term Memory (# correct) | Hopkins Verbal Learning Task (HVLT) | Baseline, 1.5 hour and 3.5 hours post beverage | 
| Change in Mood (change in Likert scale score) | Profile of Mood Status (POMS) | Baseline, 1.5 hour and 3.5 hours post beverage | 
| Change in Attention (% accuracy) | Eriksen Flanker Task | Baseline, 1.5 hour and 3.5 hours post beverage | 
| Change in Executive Function (# correct) | Stroop Task | Baseline, 1.5 hour and 3.5 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 post beverage | 
| % Change in Heart Rate (beats/minute) | Pulse | before, 1 hour, and 3 hour post beverage | 
| % Change in Blood Pressure (mm Hg) |  | before, 1 hour, and 3 hour post beverage | 
| Change in Respiration (breaths/minute) |  | before, 1 hour, and 3 hour post beverage | 

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