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:

Study Overview

• Status: Completed
• Conditions: Mental Fatigue
• Intervention / Treatment: Other: Caffeinated cocoa; Other: Cocoa; Other: Caffeine; Other: Placebo

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
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: The Hershey Company
• Investigators: Principal Investigator: Patrick O'Connor, PhD, University of Georgia

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: fatigue; caffeine; energy; flavanols; theobromine; vigilance; vigor; vitality; cacao; sustained attention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Mental Fatigue; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: Study of cocoa-like beverages

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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