Effects of a Cocoa Shot on the Human Brain

Wake Forest University (WFU)

Status: Completed

Conditions: Caffeine; Flavonoids

Treatments: Dietary Supplement: High theobromine; Dietary Supplement: High Caffeine; Dietary Supplement: low theobromine; Dietary Supplement: Low caffeine; Dietary Supplement: No theobromine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01924481

IRB00023752

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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6 participants in 4 patient groups

low theobromine & low caffeine

Experimental group

Description:

Drink 1

Treatment:

Dietary Supplement: Low caffeine

Dietary Supplement: low theobromine

low theobromine & high caffeine

Experimental group

Description:

Drink 2

Treatment:

Dietary Supplement: High Caffeine

Dietary Supplement: low theobromine

high theobromine & low caffeine

Experimental group

Description:

Drink 3

Treatment:

Dietary Supplement: Low caffeine

Dietary Supplement: High theobromine

no theobromine & high caffeine

Active Comparator group

Description:

Drink 4

Treatment:

Dietary Supplement: High Caffeine

Dietary Supplement: No theobromine