Effects of a Cocoa Shot on the Human Brain 2

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02080845

Collaborator

The Hershey Company (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Mar 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in Working Memory (% correct) [Baseline, 1.5 hour and 3.5 hours post beverage]
N-Back 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 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 Executive Function (# correct) [Baseline, 1.5 hour and 3.5 hours post beverage]
Stroop Task

Secondary Outcome Measures

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 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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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