Skip to main content
OpenTrials
Completed

NCT Number: NCT01651793

Effect of Phytochemicals From Theobroma Cacao on Mental Energy

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:

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mental Fatigue Behavior Behavioral Symptoms Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia

Athens, Georgia, 30602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeinated cocoa

Other

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

Cocoa

Other

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

Caffeine

Other

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

Placebo

Other

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

Primary outcomes

  1. Correct Responses on Serial 7 Subtraction Task

    Time frame: Pre and 30, 60 and 120 minutes post intervention

    Participants subtract the number 7 from a three digit number and quickly and accurately as possible for 60 seconds. The total number of accurate responses is scored. The higher the score the better performance. The range of scores is from a minimum score of 0 to a theoretical maximum score of 120.

  2. Performance on Bakan Task

    Time frame: baseline, post 60, post 90, post 120

    Performance on Bakan Task at baseline, post-test 1, post-test 2, and post-test 3

    Bakan test presents numbers on a computer screen. Participant presses one button whenever the number 6 appears and a different button whenever three odd and different numbers in a row occurs such as 7 5 9. The number of times the participant does this correctly the better the performance. The scores range from 0 to 10 because the sequence of three odd and different numbers occurs a total of 10 times.

Secondary outcomes

  1. Vigor Symptoms (Profile of Mood State)

    Time frame: Pre and 90, 120 and 160 minutes post intervention

    Vigor subscale scores from the Profile of Mood States.The higher the score the greater the feelings of energy. The scores range from a minimum of 0 to a maximum of 20.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • The Hershey Company

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 27, 2012
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.