Effect of Phytochemicals From Theobroma Cacao on Mental Energy

University of Georgia (UGA)

Status: Completed

Conditions: Mental Fatigue

Treatments: Other: Caffeinated cocoa; Other: Cocoa; Other: Placebo; Other: Caffeine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01651793

Study of cocoa-like beverages

Details and patient eligibility

About

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:

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Caffeinated cocoa

Active Comparator group

Description:

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

Treatment:

Other: Caffeinated cocoa

Cocoa

Active Comparator group

Description:

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

Treatment:

Other: Cocoa

Caffeine

Active Comparator group

Description:

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

Treatment:

Other: Caffeine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo