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Effect of Phytochemicals From Theobroma Cacao on Mental Energy

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ClinicalTrials.gov Identifier: NCT01651793
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
The Hershey Company
Information provided by (Responsible Party):
Patrick O'Connor, University of Georgia

Brief Summary:
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:

Condition or disease Intervention/treatment Phase
Mental Fatigue Other: Caffeinated cocoa Other: Cocoa Other: Caffeine Other: Placebo Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Study Start Date : July 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Fatigue

Arm Intervention/treatment
Active Comparator: Caffeinated cocoa
High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
Other: Caffeinated cocoa
70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener

Active Comparator: Cocoa
High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
Other: Cocoa
21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener

Active Comparator: Caffeine
Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
Other: Caffeine
473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener

Placebo Comparator: Placebo
No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle
Other: Placebo
473 ml of brewed water, caramel coloring and one packet Truvia sweetener




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651793


Locations
United States, Georgia
University of Georgia
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
The Hershey Company
Investigators
Principal Investigator: Patrick O'Connor, PhD University of Georgia

Responsible Party: Patrick O'Connor, Professor of Kinesiology, University of Georgia
ClinicalTrials.gov Identifier: NCT01651793     History of Changes
Other Study ID Numbers: Study of cocoa-like beverages
First Posted: July 27, 2012    Key Record Dates
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be kept securely at the University of Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu).
Time Frame: January 1, 2019
Access Criteria: Open Access

Keywords provided by Patrick O'Connor, University of Georgia:
cacao
theobromine
flavanols
caffeine
sustained attention
vigilance
vigor
vitality
energy
fatigue

Additional relevant MeSH terms:
Fatigue
Mental Fatigue
Signs and Symptoms
Behavioral Symptoms
Caffeine
Theobromine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents