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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
Enrollment 24

Recruitment Details

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  
Arm/Group Title Caffeinated Cocoa, Cocoa, Caffeine, Placebo Cocoa, Caffeine, Placebo, Caffeinated Cocoa Caffeine, Placebo, Caffeinated Cocoa, Cocoa Placebo, Caffeinated Cocoa, Cocoa, Caffeine
Hide Arm/Group Description Order: Caffeinated cocoa, cocoa, caffeine, Placebo; 6 participants were randomized to this order. Order: Cocoa, Caffeine, Placebo, Caffeinated Cocoa; 6 participants were randomize to receive treatment in this order. Order: Caffeine, Placebo, Caffeinated cocoa, Cocoa; 6 participants were randomized to receive treatment in this order. Order: Placebo, Caffeinated cocoa, Cocoa, Caffeine; 6 participants were randomized to receive treatment in this order.
Period Title: Overall Study
Started 6 6 6 6
Completed 6 6 6 5
Not Completed 0 0 0 1
Arm/Group Title All Completed Participants
Hide Arm/Group Description These baseline data represent all participants who completed the trial (n = 23). Data are presented as means and standard deviations where appropriate.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
20  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
17
  73.9%
Male
6
  26.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
 100.0%
Amount of sleep on a typical night in the past month (hrs)  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 23 participants
7.4  (1.1)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 23 participants
168.28  (1.19)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 23 participants
67.05  (14.87)
1.Primary Outcome
Title Correct Responses on Serial 7 Subtraction Task
Hide Description 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.
Time Frame Pre and 30, 60 and 120 minutes post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-test Post-test 1 Post-test 2 Post-test 3
Hide Arm/Group Description:
Baseline measures, pre consumption of beverages.
21-47 minutes post consumption.
57-83 minutes post consumption.
93-119 minutes post consumption.
Overall Number of Participants Analyzed 23 23 23 23
Mean (Standard Deviation)
Unit of Measure: Correct responses
Subtract 7 Correct - Placebo 40.91  (5.56) 42.57  (3.51) 43.04  (2.31) 42.13  (3.67)
Subtract 7 Correct - Caffeine 41.83  (3.56) 41.35  (3.73) 43.22  (2.92) 42.74  (3.03)
Subtract 7 Correct - Cocoa 42.57  (2.52) 42.61  (3.86) 42.78  (3.06) 42.61  (3.81)
Subtract 7 Correct - Caffeine + Cocoa 42.17  (3.24) 42.26  (2.47) 42.96  (2.33) 43.14  (2.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-test
Comments Hypotheses were tested using a series (all outcome variables) of 2 Treatment x 4 Time point, repeated measures ANCOVAs that controlled for the prior night’s sleep. Primary interests were the presence of statistically significant interactions of time and either cocoa versus placebo, cocoa + caffeine versus cocoa, or cocoa + caffeine versus caffeine-only. Significant interactions were decomposed using one-way ANOVAs and t-tests with familywise error controlled using LSD post-hoc tests.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments P value reference to the beverage x time interaction effect
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Performance on Bakan Task
Hide Description

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.

Time Frame baseline, post 60, post 90, post 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-test Post-test 1 Post-test 2 Post-test 3
Hide Arm/Group Description:
Baseline measures, pre consumption of beverages.
21-47 minutes post consumption.
57-83 minutes post consumption.
93-119 minutes post consumption.
Overall Number of Participants Analyzed 23 23 23 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Bakan Primary Correct - Placebo 6.35  (1.53) 6.00  (1.57) 5.96  (2.01) 6.09  (1.95)
Bakan Primary Correct - Caffeine 6.35  (1.50) 6.57  (1.78) 6.87  (1.39) 6.13  (1.36)
Bakan Primary Correct - Cocoa 6.43  (1.59) 6.52  (1.44) 6.30  (1.11) 5.78  (1.70)
Bakan Primary Correct - Caffeine + Cocoa 5.83  (1.59) 6.13  (1.77) 6.35  (1.77) 6.61  (1.47)
3.Secondary Outcome
Title Vigor Symptoms (Profile of Mood State)
Hide Description 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.
Time Frame Pre and 90, 120 and 160 minutes post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-test Post-test 1 Post-test 2 Post-test 3
Hide Arm/Group Description:
Mood measure at baseline.
22-48 minutes post consumption.
60-86 minutes post consumption.
98-124 minutes post consumption.
Overall Number of Participants Analyzed 23 23 23 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
POMS Vigor - Placebo 3.78  (4.36) 3.57  (4.00) 3.52  (3.44) 3.65  (3.68)
POMS Vigor - Caffeine 3.91  (3.66) 3.91  (3.99) 4.00  (3.92) 4.26  (3.29)
POMS Vigor - Cocoa 3.65  (4.01) 3.74  (3.45) 4.00  (3.84) 3.70  (3.30)
POMS Vigor - Caffeinated Cocoa 4.09  (4.43) 4.48  (4.28) 4.04  (4.03) 4.17  (3.87)
Time Frame The study personnel monitored participants through study completion, an average of 4 weeks, for adverse events. No adverse events were reported to study personnel.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Caffeinated Cocoa Cocoa Cafeine Placebo
Hide Arm/Group Description

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

Active comparator 1: High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle

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

Active comparator 2: High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle

Low flavanol, low 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

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

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

All-Cause Mortality
Caffeinated Cocoa Cocoa Cafeine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Caffeinated Cocoa Cocoa Cafeine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Caffeinated Cocoa Cocoa Cafeine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
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.
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
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