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Completed

NCT Number: NCT01924481

Effects of a Cocoa Shot on the Human Brain

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.

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Key information

Conditions

Caffeine Flavonoids

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Caffeine

Dietary Supplement

Low caffeine

Dietary Supplement

High theobromine

Dietary Supplement

low theobromine

Dietary Supplement

No theobromine

Dietary Supplement

Primary outcomes

  1. Change in Working Memory (% correct)

    Time frame: before, 1 hour and 3 hours post beverage

    N-Back Task

  2. Change in Response Time (milliseconds)

    Time frame: before, 1 hour and 3 hours post beverage

    Simple Response Time Task

  3. Change in Short Term Memory (# correct)

    Time frame: before, 1 hour and 3 hours post beverage

    Hopkins Verbal Learning Task (HVLT)

  4. Change in Mood (change in Likert scale score)

    Time frame: before, 1 hour and 3 hours post beverage

    Profile of Mood Status(POMS)

  5. Change in Attention (% accuracy)

    Time frame: before, 1 hour and 3 hours post beverage

    Eriksen Flanker Task

  6. Change in Executive Function (# correct)

    Time frame: before, 1 hour and 3 hours post beverage

    Stroop Task

Secondary outcomes

  1. Change in Brain Blood Flow (ml/g/min)

    Time frame: 1 hour and 3 hours post beverage

    Non-invasive brain perfusion measured with arterial spin labeling magnetic resonance imaging

  2. % Change in Heart Rate (beats/minute)

    Time frame: before, 1 hour and 3 hours post beverage

    pulse

  3. % Change in Respiration (breaths/minute)

    Time frame: before, 1 hour and 3 hours post beverage

  4. % Change in Blood Pressure (mmHg)

    Time frame: before, 1 hour and 3 hours post beverage

Other outcomes

  1. % Change in Brain Connectivity (network degree)

    Time frame: 1 hour and 3 hours post beverage

    Measures of functional brain connectivity based on resting-state functional magnetic resonance imaging.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • The Hershey Company

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2013
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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