Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Primary Purpose
Mental Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeinated cocoa
Cocoa
Caffeine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Mental Fatigue focused on measuring cacao, theobromine, flavanols, caffeine, sustained attention, vigilance, vigor, vitality, energy, fatigue
Eligibility 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
Sites / Locations
- University of Georgia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Caffeinated cocoa
Cocoa
Caffeine
Placebo
Arm Description
High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle
Outcomes
Primary Outcome Measures
Correct Responses on Serial 7 Subtraction Task
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.
Performance on Bakan Task
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
Vigor Symptoms (Profile of Mood State)
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.
Full Information
NCT ID
NCT01651793
First Posted
July 25, 2012
Last Updated
June 20, 2018
Sponsor
University of Georgia
Collaborators
The Hershey Company
1. Study Identification
Unique Protocol Identification Number
NCT01651793
Brief Title
Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Official Title
Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
The Hershey Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Fatigue
Keywords
cacao, theobromine, flavanols, caffeine, sustained attention, vigilance, vigor, vitality, energy, fatigue
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caffeinated cocoa
Arm Type
Active Comparator
Arm Description
High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
Arm Title
Cocoa
Arm Type
Active Comparator
Arm Description
High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
Arm Title
Caffeine
Arm Type
Active Comparator
Arm Description
Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle
Intervention Type
Other
Intervention Name(s)
Caffeinated cocoa
Intervention Description
70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
Intervention Type
Other
Intervention Name(s)
Cocoa
Intervention Description
21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
Intervention Type
Other
Intervention Name(s)
Caffeine
Intervention Description
473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
473 ml of brewed water, caramel coloring and one packet Truvia sweetener
Primary Outcome Measure Information:
Title
Correct Responses on Serial 7 Subtraction Task
Description
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.
Time Frame
Pre and 30, 60 and 120 minutes post intervention
Title
Performance on Bakan Task
Description
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.
Time Frame
baseline, post 60, post 90, post 120
Secondary Outcome Measure Information:
Title
Vigor Symptoms (Profile of Mood State)
Description
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.
Time Frame
Pre and 90, 120 and 160 minutes post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick O'Connor, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
IPD Sharing Time Frame
January 1, 2019
IPD Sharing Access Criteria
Open Access
Learn more about this trial
Effect of Phytochemicals From Theobroma Cacao on Mental Energy
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