Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2013-09-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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low theobromine & low caffeine
Drink 1
Low caffeine
low theobromine
low theobromine & high caffeine
Drink 2
High Caffeine
low theobromine
high theobromine & low caffeine
Drink 3
Low caffeine
High theobromine
no theobromine & high caffeine
Drink 4
High Caffeine
No theobromine
Interventions
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High Caffeine
Low caffeine
High theobromine
low theobromine
No theobromine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
38 Years
ALL
Yes
Sponsors
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The Hershey Company
INDUSTRY
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Paul J. Laurienti, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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IRB00023752
Identifier Type: -
Identifier Source: org_study_id
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