- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01924481
Effects of a Cocoa Shot on the Human Brain
July 16, 2018 updated by: Wake Forest University Health Sciences
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: low theobromine & low caffeine
Drink 1
|
|
EXPERIMENTAL: low theobromine & high caffeine
Drink 2
|
|
EXPERIMENTAL: high theobromine & low caffeine
Drink 3
|
|
ACTIVE_COMPARATOR: no theobromine & high caffeine
Drink 4
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Working Memory (% correct)
Time Frame: before, 1 hour and 3 hours post beverage
|
N-Back Task
|
before, 1 hour and 3 hours post beverage
|
Change in Response Time (milliseconds)
Time Frame: before, 1 hour and 3 hours post beverage
|
Simple Response Time Task
|
before, 1 hour and 3 hours post beverage
|
Change in Short Term Memory (# correct)
Time Frame: before, 1 hour and 3 hours post beverage
|
Hopkins Verbal Learning Task (HVLT)
|
before, 1 hour and 3 hours post beverage
|
Change in Mood (change in Likert scale score)
Time Frame: before, 1 hour and 3 hours post beverage
|
Profile of Mood Status(POMS)
|
before, 1 hour and 3 hours post beverage
|
Change in Attention (% accuracy)
Time Frame: before, 1 hour and 3 hours post beverage
|
Eriksen Flanker Task
|
before, 1 hour and 3 hours post beverage
|
Change in Executive Function (# correct)
Time Frame: before, 1 hour and 3 hours post beverage
|
Stroop Task
|
before, 1 hour and 3 hours post beverage
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Brain Blood Flow (ml/g/min)
Time Frame: 1 hour and 3 hours post beverage
|
Non-invasive brain perfusion measured with arterial spin labeling magnetic resonance imaging
|
1 hour and 3 hours post beverage
|
% Change in Heart Rate (beats/minute)
Time Frame: before, 1 hour and 3 hours post beverage
|
pulse
|
before, 1 hour and 3 hours post beverage
|
% Change in Respiration (breaths/minute)
Time Frame: before, 1 hour and 3 hours post beverage
|
before, 1 hour and 3 hours post beverage
|
|
% Change in Blood Pressure (mmHg)
Time Frame: before, 1 hour and 3 hours post beverage
|
before, 1 hour and 3 hours post beverage
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% Change in Brain Connectivity (network degree)
Time Frame: 1 hour and 3 hours post beverage
|
Measures of functional brain connectivity based on resting-state functional magnetic resonance imaging.
|
1 hour and 3 hours post beverage
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paul J. Laurienti, MD, PhD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (ACTUAL)
October 1, 2013
Study Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
August 13, 2013
First Submitted That Met QC Criteria
August 14, 2013
First Posted (ESTIMATE)
August 16, 2013
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
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
- IRB00023752
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Caffeine
-
Ain Shams UniversityCompletedCaffeine | Caffeine Withdrawal | Caffeine DependenceEgypt
-
Psychiatric Hospital of the University of BaselSwiss National Science FoundationCompletedSleep | Circadian Rhythm | Caffeine | Caffeine WithdrawalSwitzerland
-
St. Mary's University, TwickenhamNot yet recruiting
-
St Mary's University CollegeNot yet recruiting
-
Wake Forest University Health SciencesThe Hershey CompanyCompleted
-
Technical University of LisbonCompleted
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedSleep Disorder | Diarrhea | Anxiety Disorders | Insomnia | Sleep Initiation and Maintenance Disorders | Anxiety | Sleep Disturbance | Gastrointestinal Dysfunction | Heartburn | Caffeine | Caffeine Withdrawal | Caffeine; Sleep Disorder | Caffeine Dependence | Caffeine-Induced Anxiety Disorder | Caffeine-Induced Sleep... and other conditionsUnited States
-
National Taiwan Sport UniversityCompleted
-
Vedic Lifesciences Pvt. Ltd.Completed
-
Carolin ReichertPontificia Universidad Catolica de Chile; Swiss National Science Foundation; University...Completed
Clinical Trials on Low caffeine
-
St. Mary's University, TwickenhamNot yet recruiting
-
Université de SherbrookeCompleted
-
State University of New York at BuffaloCompleted
-
University of Sao PauloCompletedEvaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive TherapiesGingival Recession | Gingival Recession, GeneralizedBrazil
-
Wake Forest University Health SciencesThe Hershey CompanyCompleted
-
Southern Illinois University CarbondaleCompleted
-
University of ReadingCompletedCardiovascular DiseaseUnited Kingdom
-
Sharp HealthCareCompletedCaffeineUnited States
-
University of TorontoCanadian Institutes of Health Research (CIHR); Nutrigenomix Inc.Unknown
-
Pennington Biomedical Research CenterCompletedHealthy VolunteersUnited States