Effect of Phytochemicals From Theobroma Cacao on Mental Energy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to determine which substances in cocoa produces changes in mental energy. This is a double blind study. The primary outcome measures are performance on tasks of sustained attention (serial subtract, continuous performance test and Bakan task) at pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile of mood state), and ratings of motivation to perform cognitive tasks. The assigned interventions are the following:

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Detailed Description

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Only one prior study has examined the acute influence of cocoa on mental energy. The purpose of this research is to replicate the previous observations and extend research in four ways: 1) start to determine which substance in cocoa responsible for the effect by including several comparison groups, 2) focus on individuals with average or below average symptoms of mental energy and who are not high consumers of fruits, vegetables and other products containing high amounts of flavonoids in order to learn whether people with low energy accrue a greater benefit, and 3) include additional measures of mental energy plausibly influenced by cocoa to better understand the health consequences of cocoa.

Conditions

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Mental Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Caffeinated cocoa

High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle

Group Type ACTIVE_COMPARATOR

Caffeinated cocoa

Intervention Type OTHER

70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener

Cocoa

High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle

Group Type ACTIVE_COMPARATOR

Cocoa

Intervention Type OTHER

21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener

Caffeine

Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle

Group Type ACTIVE_COMPARATOR

Caffeine

Intervention Type OTHER

473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener

Placebo

No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

473 ml of brewed water, caramel coloring and one packet Truvia sweetener

Interventions

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Caffeinated cocoa

70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener

Intervention Type OTHER

Cocoa

21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener

Intervention Type OTHER

Caffeine

473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener

Intervention Type OTHER

Placebo

473 ml of brewed water, caramel coloring and one packet Truvia sweetener

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women and men ages 18-34
* Lower than average feelings of energy (score of \< 13 on Profile of Mood States Vigor scale)

Exclusion Criteria

* Pregnant
* GI tract disorder
* Psychoactive medication use
* Daily consumption of \> 200 mg caffeine
* Body mass index \> 30
* Cigarette smoker
* Allergy to cocoa, chocolate or caffeine
* Frequent consumption of cocoa, chocolate-based products or fruits and vegetable containing flavonoids

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes