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Effects of a Cocoa Shot on the Human Brain 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02080845
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
The Hershey Company
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Caffeine Dietary Supplement: no caffeine Dietary Supplement: high caffeine Dietary Supplement: no theobromine Dietary Supplement: low theobromine Dietary Supplement: high theobromine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of a Cocoa Shot on the Human Brain 2
Study Start Date : March 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Placebo Comparator: no caffeine & no theobromine
Drink 1
Dietary Supplement: no caffeine
Dietary Supplement: no theobromine
Experimental: no caffeine & low theobromine
Drink 2
Dietary Supplement: no caffeine
Dietary Supplement: low theobromine
Experimental: no caffeine & high theobromine
Drink 3
Dietary Supplement: no caffeine
Dietary Supplement: high theobromine
Experimental: high caffeine & no theobromine
Drink 4
Dietary Supplement: high caffeine
Dietary Supplement: no theobromine



Primary Outcome Measures :
  1. Change in Working Memory (% correct) [ Time Frame: Baseline, 1.5 hour and 3.5 hours post beverage ]
    N-Back Task

  2. Change in Response Time (milliseconds) [ Time Frame: Baseline, 1.5 hour and 3.5 hours post beverage ]
    Choice ResponseTime Task

  3. Change in Short Term Memory (# correct) [ Time Frame: Baseline, 1.5 hour and 3.5 hours post beverage ]
    Hopkins Verbal Learning Task (HVLT)

  4. Change in Mood (change in Likert scale score) [ Time Frame: Baseline, 1.5 hour and 3.5 hours post beverage ]
    Profile of Mood Status (POMS)

  5. Change in Attention (% accuracy) [ Time Frame: Baseline, 1.5 hour and 3.5 hours post beverage ]
    Eriksen Flanker Task

  6. Change in Executive Function (# correct) [ Time Frame: Baseline, 1.5 hour and 3.5 hours post beverage ]
    Stroop Task


Secondary Outcome Measures :
  1. Change in Brain Blood Flow (ml/g/min) [ Time Frame: 1 hour 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 hour post beverage ]
    Pulse

  3. % Change in Blood Pressure (mm Hg) [ Time Frame: before, 1 hour, and 3 hour post beverage ]
  4. Change in Respiration (breaths/minute) [ Time Frame: before, 1 hour, and 3 hour post beverage ]

Other Outcome Measures:
  1. % Change in Brain Connectivity (network degree) [ Time Frame: 1 hour post beverage ]
    Measures of functional brain connectivity based on resting-state functional magnetic resonance imaging.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080845


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
The Hershey Company
Investigators
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Principal Investigator: Paul J Laurient, MD, PhD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02080845     History of Changes
Other Study ID Numbers: IRB00026868
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Caffeine
MRI
Brain blood flow
Cognition
Perfusion
Resting functional magnetic resonance imaging (fMRI)
Additional relevant MeSH terms:
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Theobromine
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents