Clinical trial NCT01924481: Effects of a Cocoa Shot on the Human Brain
Official title: Effects of a Cocoa Shot on the Human Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Flavonoids
Keywords: Caffeine
Flavonoids
MRI
Brain blood flow
Cognition
Perfusion
Resting functional magnetic resonance imaging (fMRI)
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Hershey Company
First posted: 2013-08-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Working Memory (% correct)
timeFrame: before, 1 hour and 3 hours post beverage
measure: Change in Response Time (milliseconds)
timeFrame: before, 1 hour and 3 hours post beverage
measure: Change in Short Term Memory (# correct)
timeFrame: before, 1 hour and 3 hours post beverage
measure: Change in Mood (change in Likert scale score)
timeFrame: before, 1 hour and 3 hours post beverage
measure: Change in Attention (% accuracy)
timeFrame: before, 1 hour and 3 hours post beverage
measure: Change in Executive Function (# correct)
timeFrame: before, 1 hour and 3 hours post beverage
Secondary outcomes:
measure: Change in Brain Blood Flow (ml/g/min)
timeFrame: 1 hour and 3 hours post beverage
measure: % Change in Heart Rate (beats/minute)
timeFrame: before, 1 hour and 3 hours post beverage
measure: % Change in Respiration (breaths/minute)
timeFrame: before, 1 hour and 3 hours post beverage
measure: % Change in Blood Pressure (mmHg)
timeFrame: before, 1 hour and 3 hours post beverage
Other outcomes:
measure: % Change in Brain Connectivity (network degree)
timeFrame: 1 hour and 3 hours post beverage
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Paul J. Laurienti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: