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Effect of Phytochemicals From Theobroma Cacao on Mental Energy

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ClinicalTrials.gov Identifier: NCT01651793
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
The Hershey Company
Information provided by (Responsible Party):
Patrick O'Connor, University of Georgia

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Mental Fatigue
Interventions: Other: Caffeinated cocoa
Other: Cocoa
Other: Caffeine
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Potential participants were recruited from (i) large university classes, (ii) announcements on buses, bulletin boards, and electronic listservs, and (iii) through word of mouth. Potential participants were invited to complete screening questionnaires (medical history, diet, mood) administered online using Zoomerang

>http://www.zoomerang.com/<.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Caffeinated Cocoa, Cocoa, Caffeine, Placebo Order: Caffeinated cocoa, cocoa, caffeine, Placebo; 6 participants were randomized to this order.
Cocoa, Caffeine, Placebo, Caffeinated Cocoa Order: Cocoa, Caffeine, Placebo, Caffeinated Cocoa; 6 participants were randomize to receive treatment in this order.
Caffeine, Placebo, Caffeinated Cocoa, Cocoa Order: Caffeine, Placebo, Caffeinated cocoa, Cocoa; 6 participants were randomized to receive treatment in this order.
Placebo, Caffeinated Cocoa, Cocoa, Caffeine Order: Placebo, Caffeinated cocoa, Cocoa, Caffeine; 6 participants were randomized to receive treatment in this order.

Participant Flow:   Overall Study
    Caffeinated Cocoa, Cocoa, Caffeine, Placebo   Cocoa, Caffeine, Placebo, Caffeinated Cocoa   Caffeine, Placebo, Caffeinated Cocoa, Cocoa   Placebo, Caffeinated Cocoa, Cocoa, Caffeine
STARTED   6   6   6   6 
COMPLETED   6   6   6   5 
NOT COMPLETED   0   0   0   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Completed Participants These baseline data represent all participants who completed the trial (n = 23). Data are presented as means and standard deviations where appropriate.

Baseline Measures
   All Completed Participants 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Years]
Mean (Standard Deviation)
 20  (2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      17  73.9% 
Male      6  26.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      6  26.1% 
White      15  65.2% 
More than one race      2   8.7% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   23 
Amount of sleep on a typical night in the past month (hrs) 
[Units: Hours]
Mean (Standard Deviation)
 7.4  (1.1) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 168.28  (1.19) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 67.05  (14.87) 


  Outcome Measures

1.  Primary:   Correct Responses on Serial 7 Subtraction Task   [ Time Frame: Pre and 30, 60 and 120 minutes post intervention ]

2.  Primary:   Performance on Bakan Task   [ Time Frame: baseline, post 60, post 90, post 120 ]

3.  Secondary:   Vigor Symptoms (Profile of Mood State)   [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Patrick J. O'Connor
Organization: University of Georgia
phone: 706-542-4382
e-mail: poconnor@uga.edu



Responsible Party: Patrick O'Connor, University of Georgia
ClinicalTrials.gov Identifier: NCT01651793     History of Changes
Other Study ID Numbers: Study of cocoa-like beverages
First Submitted: July 25, 2012
First Posted: July 27, 2012
Results First Submitted: January 19, 2017
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018