Effects of a Cocoa Shot on the Human Brain 2

Not Applicable

Completed

• Conditions: Caffeine
• Interventions: Dietary Supplement: high caffeine; Dietary Supplement: no caffeine; Dietary Supplement: no theobromine; Dietary Supplement: low theobromine; Dietary Supplement: high theobromine

• Registration Number: NCT02080845
• Lead Sponsor: Wake Forest University Health Sciences

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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
high caffeine & no theobromine	high caffeine	Drink 4
no caffeine & no theobromine	no theobromine	Drink 1
no caffeine & low theobromine	no caffeine	Drink 2
no caffeine & low theobromine	low theobromine	Drink 2
high caffeine & no theobromine	no theobromine	Drink 4
no caffeine & high theobromine	no caffeine	Drink 3
no caffeine & no theobromine	no caffeine	Drink 1
no caffeine & high theobromine	high theobromine	Drink 3

Primary Outcome Measures

Name	Time	Method
Change in Working Memory (% correct)	Baseline, 1.5 hour and 3.5 hours post beverage	N-Back Task
Change in Mood (change in Likert scale score)	Baseline, 1.5 hour and 3.5 hours post beverage	Profile of Mood Status (POMS)
Change in Attention (% accuracy)	Baseline, 1.5 hour and 3.5 hours post beverage	Eriksen Flanker Task
Change in Response Time (milliseconds)	Baseline, 1.5 hour and 3.5 hours post beverage	Choice ResponseTime Task
Change in Short Term Memory (# correct)	Baseline, 1.5 hour and 3.5 hours post beverage	Hopkins Verbal Learning Task (HVLT)
Change in Executive Function (# correct)	Baseline, 1.5 hour and 3.5 hours post beverage	Stroop Task

Secondary Outcome Measures

Name	Time	Method
% Change in Blood Pressure (mm Hg)	before, 1 hour, and 3 hour post beverage
Change in Brain Blood Flow (ml/g/min)	1 hour post beverage	Non-invasive brain perfusion measured with arterial spin labeling magnetic resonance imaging
% Change in Heart Rate (beats/minute)	before, 1 hour, and 3 hour post beverage	Pulse
Change in Respiration (breaths/minute)	before, 1 hour, and 3 hour post beverage

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States