Effect of Phytochemicals From Theobroma Cacao on Mental Energy

Mental Fatigue Clinical Trial

Official title:

Effect of Phytochemicals From Theobroma Cacao on Mental Energy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651793
• Other study ID #: Study of cocoa-like beverages
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2018
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Mental Fatigue

Intervention

Other:
• Caffeinated cocoa
70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
• Cocoa
21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
• Caffeine
473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener
• Placebo
473 ml of brewed water, caramel coloring and one packet Truvia sweetener

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	The Hershey Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre and 30, 60 and 120 minutes post intervention
Primary	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.	baseline, post 60, post 90, post 120
Secondary	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.	Pre and 90, 120 and 160 minutes post intervention