Effects of a Cocoa Shot on the Human Brain 2

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.

Study Overview

• Status: Completed
• Conditions: Caffeine
• Intervention / Treatment: Dietary supplement: low theobromine; Dietary supplement: no caffeine; Dietary supplement: no theobromine; Dietary supplement: high theobromine; Dietary supplement: high caffeine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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: low theobromine; Dietary supplement: no caffeine
EXPERIMENTAL: no caffeine & high theobromine; Drink 3	Dietary supplement: no caffeine; Dietary supplement: high theobromine
EXPERIMENTAL: high caffeine & no theobromine; Drink 4	Dietary supplement: no theobromine; Dietary supplement: high caffeine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: The Hershey Company
• Investigators: Principal Investigator: Paul J Laurient, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (ESTIMATE): March 6, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: MRI; Cognition; Caffeine; Perfusion; Brain blood flow; Resting functional magnetic resonance imaging (fMRI)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine; Theobromine
• Other Study ID Numbers: IRB00026868

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No