Caffeine, Flavonoids
Conditions
Keywords
Caffeine, Flavonoids, MRI, Brain blood flow, Cognition, Perfusion, Resting functional magnetic resonance imaging (fMRI)
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) 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.
Interventions
DIETARY_SUPPLEMENTHigh theobromine
DIETARY_SUPPLEMENTlow theobromine
DIETARY_SUPPLEMENTNo theobromine
DIETARY_SUPPLEMENTHigh Caffeine
DIETARY_SUPPLEMENTLow caffeine
Sponsors
The Hershey Company
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 38 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Executive Function (# correct) | before, 1 hour and 3 hours post beverage | Stroop Task |
| Change in Working Memory (% correct) | before, 1 hour and 3 hours post beverage | N-Back Task |
| Change in Response Time (milliseconds) | before, 1 hour and 3 hours post beverage | Simple Response Time Task |
| Change in Short Term Memory (# correct) | before, 1 hour and 3 hours post beverage | Hopkins Verbal Learning Task (HVLT) |
| Change in Mood (change in Likert scale score) | before, 1 hour and 3 hours post beverage | Profile of Mood Status(POMS) |
| Change in Attention (% accuracy) | before, 1 hour and 3 hours post beverage | Eriksen Flanker Task |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain Blood Flow (ml/g/min) | 1 hour and 3 hours 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 hours post beverage | pulse |
| % Change in Respiration (breaths/minute) | before, 1 hour and 3 hours post beverage | — |
| % Change in Blood Pressure (mmHg) | before, 1 hour and 3 hours post beverage | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| % Change in Brain Connectivity (network degree) | 1 hour and 3 hours post beverage | Measures of functional brain connectivity based on resting-state functional magnetic resonance imaging. |
Countries
United States
Outcome results
None listed