Effects of a Cocoa Shot on the Human Brain 2

Caffeine Clinical Trial

Official title:

Effects of a Cocoa Shot on the Human Brain 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080845
• Other study ID #: IRB00026868
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Caffeine

Intervention

Dietary Supplement:
• no caffeine

• high caffeine

• no theobromine

• low theobromine

• high theobromine

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	The Hershey Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	% Change in Brain Connectivity (network degree)	Measures of functional brain connectivity based on resting-state functional magnetic resonance imaging.	1 hour post beverage
Primary	Change in Working Memory (% correct)	N-Back Task	Baseline, 1.5 hour and 3.5 hours post beverage
Primary	Change in Response Time (milliseconds)	Choice ResponseTime Task	Baseline, 1.5 hour and 3.5 hours post beverage
Primary	Change in Short Term Memory (# correct)	Hopkins Verbal Learning Task (HVLT)	Baseline, 1.5 hour and 3.5 hours post beverage
Primary	Change in Mood (change in Likert scale score)	Profile of Mood Status (POMS)	Baseline, 1.5 hour and 3.5 hours post beverage
Primary	Change in Attention (% accuracy)	Eriksen Flanker Task	Baseline, 1.5 hour and 3.5 hours post beverage
Primary	Change in Executive Function (# correct)	Stroop Task	Baseline, 1.5 hour and 3.5 hours post beverage
Secondary	Change in Brain Blood Flow (ml/g/min)	Non-invasive brain perfusion measured with arterial spin labeling magnetic resonance imaging	1 hour post beverage
Secondary	% Change in Heart Rate (beats/minute)	Pulse	before, 1 hour, and 3 hour post beverage
Secondary	% Change in Blood Pressure (mm Hg)		before, 1 hour, and 3 hour post beverage
Secondary	Change in Respiration (breaths/minute)		before, 1 hour, and 3 hour post beverage