Effect of Phytochemicals From Theobroma Cacao on Mental Energy

This study is currently recruiting participants.
Verified July 2012 by University of Georgia
Sponsor:
Collaborator:
The Hershey Company
Information provided by (Responsible Party):
Patrick O'Connor, University of Georgia
ClinicalTrials.gov Identifier:
NCT01651793
First received: July 25, 2012
Last updated: July 26, 2012
Last verified: July 2012

July 25, 2012
July 26, 2012
July 2012
June 2013   (final data collection date for primary outcome measure)
Performance on tasks of sustained attention (serial subtraction, continuous performance test and Bakan task) [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01651793 on ClinicalTrials.gov Archive Site
Energy and fatigue symptoms (Profile of Mood State) [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ]
Same as current
Ratings of motivation to perform cognitive tasks [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ]
Same as current
 
Effect of Phytochemicals From Theobroma Cacao on Mental Energy
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:

Active comparator 1 High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 2 High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle Active comparator 3 Low flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 4 Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle Inactive comparator No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Mental Fatigue
  • Other: Active comparator 1
    High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
  • Other: Active comparator 2
    High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
  • Other: Active comparator 3
    Low flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
  • Other: Active comparator 4
    Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
  • Other: Inactive comparator
    No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle
  • Active Comparator: Active comparator 1
    High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
    Intervention: Other: Active comparator 1
  • Active Comparator: Active comparator 2
    High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
    Intervention: Other: Active comparator 2
  • Active Comparator: Active comparator 3
    Low flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
    Intervention: Other: Active comparator 3
  • Active Comparator: Active comparator 4
    Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
    Intervention: Other: Active comparator 4
  • Placebo Comparator: Inactive comparator
    No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle
    Intervention: Other: Inactive comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 34 Years
Yes
Contact: Ali Boolani, PhD 504-319-5828 aboolani@uga.edu
Contact: Patrick O'Connor, PhD 7065424382 poconnor@uga.edu
United States
 
NCT01651793
Study of cocoa-like beverages
No
Patrick O'Connor, University of Georgia
University of Georgia
The Hershey Company
Principal Investigator: Patrick O'Connor, PhD University of Georgia
University of Georgia
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP