Effects of a Cocoa Shot on the Human Brain 2

NCT02080845 | Completed

• 1 other identifier: IRB00026868
• Study Type: interventional
• Target: 24
• 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. 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.

Conditions

Caffeine

Keywords

Caffeine; 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

  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 Outcomes (4)

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

  1 hour post beverage

• % Change in Heart Rate (beats/minute)

  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 Outcomes (1)

• % Change in Brain Connectivity (network degree)

  1 hour post beverage

Study Arms (4)

no caffeine & no theobromine

PLACEBO COMPARATOR

Drink 1

Dietary Supplement: no caffeine; Dietary Supplement: no theobromine

no caffeine & low theobromine

EXPERIMENTAL

Drink 2

Dietary Supplement: no caffeine; Dietary Supplement: low theobromine

no caffeine & high theobromine

EXPERIMENTAL

Drink 3

Dietary Supplement: no caffeine; Dietary Supplement: high theobromine

high caffeine & no theobromine

EXPERIMENTAL

Drink 4

Dietary Supplement: high caffeine; Dietary Supplement: no theobromine

Interventions

no caffeine DIETARY_SUPPLEMENT

no caffeine & high theobromine; no caffeine & low theobromine; no caffeine & no theobromine

high caffeine DIETARY_SUPPLEMENT

high caffeine & no theobromine

no theobromine DIETARY_SUPPLEMENT

high caffeine & no theobromine; no caffeine & no theobromine

low theobromine DIETARY_SUPPLEMENT

no caffeine & low theobromine

high theobromine DIETARY_SUPPLEMENT

no caffeine & high theobromine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• 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

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

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paul J Laurient, 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: March 4, 2014
• First Posted: March 6, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

US (1)