Effects of a Cocoa Shot on the Human Brain

NCT01924481 | Completed

• 1 other identifier: IRB00023752
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Caffeine; Flavonoids

Keywords

Caffeine; Flavonoids; MRI; Brain blood flow; Cognition; Perfusion; Resting functional magnetic resonance imaging (fMRI)

Outcome Measures

Primary Outcomes (6)

• Change in Working Memory (% correct)

  N-Back Task

  before, 1 hour and 3 hours post beverage

• Change in Response Time (milliseconds)

  Simple Response Time Task

  before, 1 hour and 3 hours post beverage

• Change in Short Term Memory (# correct)

  Hopkins Verbal Learning Task (HVLT)

  before, 1 hour and 3 hours post beverage

• Change in Mood (change in Likert scale score)

  Profile of Mood Status(POMS)

  before, 1 hour and 3 hours post beverage

• Change in Attention (% accuracy)

  Eriksen Flanker Task

  before, 1 hour and 3 hours post beverage

• Change in Executive Function (# correct)

  Stroop Task

  before, 1 hour and 3 hours post beverage

Secondary Outcomes (4)

• Change in Brain Blood Flow (ml/g/min)

  1 hour and 3 hours post beverage

• % Change in Heart Rate (beats/minute)

  before, 1 hour and 3 hours post beverage

• % Change in Respiration (breaths/minute)

  before, 1 hour and 3 hours post beverage

• % Change in Blood Pressure (mmHg)

  before, 1 hour and 3 hours post beverage

Other Outcomes (1)

• % Change in Brain Connectivity (network degree)

  1 hour and 3 hours post beverage

Study Arms (4)

low theobromine & low caffeine

EXPERIMENTAL

Drink 1

Dietary Supplement: Low caffeine; Dietary Supplement: low theobromine

low theobromine & high caffeine

EXPERIMENTAL

Drink 2

Dietary Supplement: High Caffeine; Dietary Supplement: low theobromine

high theobromine & low caffeine

EXPERIMENTAL

Drink 3

Dietary Supplement: Low caffeine; Dietary Supplement: High theobromine

no theobromine & high caffeine

ACTIVE COMPARATOR

Drink 4

Dietary Supplement: High Caffeine; Dietary Supplement: No theobromine

Interventions

High Caffeine DIETARY_SUPPLEMENT

low theobromine & high caffeine; no theobromine & high caffeine

Low caffeine DIETARY_SUPPLEMENT

high theobromine & low caffeine; low theobromine & low caffeine

High theobromine DIETARY_SUPPLEMENT

high theobromine & low caffeine

low theobromine DIETARY_SUPPLEMENT

low theobromine & high caffeine; low theobromine & low caffeine

No theobromine DIETARY_SUPPLEMENT

no theobromine & high caffeine

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• The Hershey Company: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Paul J. Laurienti, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

US (1)