Effect of Phytochemicals From Theobroma Cacao on Mental Energy

NCT01651793 | Completed Results

• 1 other identifier: Study of cocoa-like beverages
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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:

Conditions

Mental Fatigue

Keywords

cacao; theobromine; flavanols; caffeine; sustained attention; vigilance; vigor; vitality; energy; fatigue

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Vigor Symptoms (Profile of Mood State)

  Pre and 90, 120 and 160 minutes post intervention

Study Arms (4)

Caffeinated cocoa

ACTIVE COMPARATOR

High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle

Other: Caffeinated cocoa

Cocoa

ACTIVE COMPARATOR

High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle

Other: Cocoa

Caffeine

ACTIVE COMPARATOR

Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle

Other: Caffeine

Placebo

PLACEBO COMPARATOR

No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle

Other: Placebo

Interventions

Caffeinated cocoa OTHER

70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener

Caffeinated cocoa

Cocoa OTHER

21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener

Cocoa

Caffeine OTHER

473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener

Caffeine

Placebo OTHER

473 ml of brewed water, caramel coloring and one packet Truvia sweetener

Placebo

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women and men ages 18-34
• Lower than average feelings of energy (score of \< 13 on Profile of Mood States Vigor scale)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• The Hershey Company: collaborator

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

MeSH Terms

Conditions

Mental Fatigue; Fatigue

Interventions

Chocolate; Caffeine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Recruitment targeted those reporting low consumption of fruits and vegetables and other foods containing flavonols; not all participants were medication-free; the potential role of sensory aspects of cocoa were not examined.

Results Point of Contact

• Title: Dr. Patrick J. O'Connor
• Organization: University of Georgia

poconnor@uga.edu

706-542-4382

Study Officials

• Patrick O'Connor, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 25, 2018
• Results First Posted: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: January 1, 2019
• Access Criteria: Open Access

Locations

US (1)