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Effect of Phytochemicals From Theobroma Cacao on Mental Energy

This study is currently recruiting participants.
Verified July 2012 by University of Georgia
Sponsor:
Collaborator:
The Hershey Company
Information provided by (Responsible Party):
Patrick O'Connor, University of Georgia
ClinicalTrials.gov Identifier:
NCT01651793
First received: July 25, 2012
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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:

Active comparator 1 High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 2 High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle Active comparator 3 Low flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 4 Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle Inactive comparator No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle


Condition Intervention
Mental Fatigue
 Other: Active comparator 1
Other: Active comparator 2
Other: Active comparator 3
Other: Active comparator 4
Other: Inactive comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Phytochemicals From Theobroma Cacao on Mental Energy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • Performance on tasks of sustained attention (serial subtraction, continuous performance test and Bakan task) [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Energy and fatigue symptoms (Profile of Mood State) [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Ratings of motivation to perform cognitive tasks [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active comparator 1
High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
 Other: Active comparator 1
High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
Active Comparator: Active comparator 2
High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
 Other: Active comparator 2
High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
Active Comparator: Active comparator 3
Low flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
 Other: Active comparator 3
Low flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
Active Comparator: Active comparator 4
Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
 Other: Active comparator 4
Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
Placebo Comparator: Inactive comparator
No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle
 Other: Inactive comparator
No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle

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.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651793

Contacts
Contact: Ali Boolani, PhD 504-319-5828 aboolani@uga.edu
Contact: Patrick O'Connor, PhD 7065424382 poconnor@uga.edu

Locations
United States, Georgia
University of Georgia Recruiting
Athens, Georgia, United States, 30602
Contact: Ali Boolani, PhD     504-319-5828     aboolani@uga.edu    
Principal Investigator: Patrick O'Connor, PhD            
Sub-Investigator: Ali Boolani, PhD            
Sponsors and Collaborators
University of Georgia
The Hershey Company
Investigators
Principal Investigator: Patrick O'Connor, PhD University of Georgia
  More Information

No publications provided

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
Study First Received: July 25, 2012
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013