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
24 participants
INTERVENTIONAL
2014-03-31
2015-03-31
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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no caffeine & no theobromine
Drink 1
no caffeine
no theobromine
no caffeine & low theobromine
Drink 2
no caffeine
low theobromine
no caffeine & high theobromine
Drink 3
no caffeine
high theobromine
high caffeine & no theobromine
Drink 4
high caffeine
no theobromine
Interventions
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no caffeine
high caffeine
no theobromine
low theobromine
high 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 10 days apart
* Willing to abstain from caffeine for 16 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
* 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
18 Years
55 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 Laurient, 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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IRB00026868
Identifier Type: -
Identifier Source: org_study_id
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