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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02080845
Other study ID # IRB00026868
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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