Effects of a Cocoa Shot on the Human Brain

NCT ID: NCT01924481

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Caffeine Flavonoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low theobromine & low caffeine

Drink 1

Group Type EXPERIMENTAL

Low caffeine

Intervention Type DIETARY_SUPPLEMENT

low theobromine

Intervention Type DIETARY_SUPPLEMENT

low theobromine & high caffeine

Drink 2

Group Type EXPERIMENTAL

High Caffeine

Intervention Type DIETARY_SUPPLEMENT

low theobromine

Intervention Type DIETARY_SUPPLEMENT

high theobromine & low caffeine

Drink 3

Group Type EXPERIMENTAL

Low caffeine

Intervention Type DIETARY_SUPPLEMENT

High theobromine

Intervention Type DIETARY_SUPPLEMENT

no theobromine & high caffeine

Drink 4

Group Type ACTIVE_COMPARATOR

High Caffeine

Intervention Type DIETARY_SUPPLEMENT

No theobromine

Intervention Type DIETARY_SUPPLEMENT

Interventions

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High Caffeine

Intervention Type DIETARY_SUPPLEMENT

Low caffeine

Intervention Type DIETARY_SUPPLEMENT

High theobromine

Intervention Type DIETARY_SUPPLEMENT

low theobromine

Intervention Type DIETARY_SUPPLEMENT

No theobromine

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hershey Company

INDUSTRY

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul J. Laurienti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00023752

Identifier Type: -

Identifier Source: org_study_id

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