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Trial Outcomes & Findings for Effect of Phytochemicals From Theobroma Cacao on Mental Energy (NCT NCT01651793)

NCT ID: NCT01651793

Last Updated: 2018-06-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Pre and 30, 60 and 120 minutes post intervention

Results posted on

2018-06-25

Participant Flow

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/\<.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
6
6
6
6
Overall Study
COMPLETED
6
6
6
5
Overall Study
NOT COMPLETED
0
0
0
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Phytochemicals From Theobroma Cacao on Mental Energy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Completed Participants
n=23 Participants
These baseline data represent all participants who completed the trial (n = 23). Data are presented as means and standard deviations where appropriate.
Age, Continuous
20 years
STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=5 Participants
Race (NIH/OMB)
White
15 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
23 Participants
n=5 Participants
Amount of sleep on a typical night in the past month (hrs)
7.4 hours
STANDARD_DEVIATION 1.1 • n=5 Participants
Height
168.28 cm
STANDARD_DEVIATION 1.19 • n=5 Participants
Weight
67.05 kg
STANDARD_DEVIATION 14.87 • n=5 Participants

PRIMARY outcome

Timeframe: Pre and 30, 60 and 120 minutes post intervention

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.

Outcome measures

Outcome measures
Measure
Pre-test
n=23 Participants
Baseline measures, pre consumption of beverages.
Post-test 1
n=23 Participants
21-47 minutes post consumption.
Post-test 2
n=23 Participants
57-83 minutes post consumption.
Post-test 3
n=23 Participants
93-119 minutes post consumption.
Correct Responses on Serial 7 Subtraction Task
Subtract 7 Correct - Cocoa
42.57 Correct responses
Standard Deviation 2.52
42.61 Correct responses
Standard Deviation 3.86
42.78 Correct responses
Standard Deviation 3.06
42.61 Correct responses
Standard Deviation 3.81
Correct Responses on Serial 7 Subtraction Task
Subtract 7 Correct - Placebo
40.91 Correct responses
Standard Deviation 5.56
42.57 Correct responses
Standard Deviation 3.51
43.04 Correct responses
Standard Deviation 2.31
42.13 Correct responses
Standard Deviation 3.67
Correct Responses on Serial 7 Subtraction Task
Subtract 7 Correct - Caffeine
41.83 Correct responses
Standard Deviation 3.56
41.35 Correct responses
Standard Deviation 3.73
43.22 Correct responses
Standard Deviation 2.92
42.74 Correct responses
Standard Deviation 3.03
Correct Responses on Serial 7 Subtraction Task
Subtract 7 Correct - Caffeine + Cocoa
42.17 Correct responses
Standard Deviation 3.24
42.26 Correct responses
Standard Deviation 2.47
42.96 Correct responses
Standard Deviation 2.33
43.14 Correct responses
Standard Deviation 2.88

PRIMARY outcome

Timeframe: baseline, post 60, post 90, post 120

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.

Outcome measures

Outcome measures
Measure
Pre-test
n=23 Participants
Baseline measures, pre consumption of beverages.
Post-test 1
n=23 Participants
21-47 minutes post consumption.
Post-test 2
n=23 Participants
57-83 minutes post consumption.
Post-test 3
n=23 Participants
93-119 minutes post consumption.
Performance on Bakan Task
Bakan Primary Correct - Placebo
6.35 units on a scale
Standard Deviation 1.53
6.00 units on a scale
Standard Deviation 1.57
5.96 units on a scale
Standard Deviation 2.01
6.09 units on a scale
Standard Deviation 1.95
Performance on Bakan Task
Bakan Primary Correct - Caffeine
6.35 units on a scale
Standard Deviation 1.50
6.57 units on a scale
Standard Deviation 1.78
6.87 units on a scale
Standard Deviation 1.39
6.13 units on a scale
Standard Deviation 1.36
Performance on Bakan Task
Bakan Primary Correct - Cocoa
6.43 units on a scale
Standard Deviation 1.59
6.52 units on a scale
Standard Deviation 1.44
6.30 units on a scale
Standard Deviation 1.11
5.78 units on a scale
Standard Deviation 1.70
Performance on Bakan Task
Bakan Primary Correct - Caffeine + Cocoa
5.83 units on a scale
Standard Deviation 1.59
6.13 units on a scale
Standard Deviation 1.77
6.35 units on a scale
Standard Deviation 1.77
6.61 units on a scale
Standard Deviation 1.47

SECONDARY outcome

Timeframe: Pre and 90, 120 and 160 minutes post intervention

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.

Outcome measures

Outcome measures
Measure
Pre-test
n=23 Participants
Baseline measures, pre consumption of beverages.
Post-test 1
n=23 Participants
21-47 minutes post consumption.
Post-test 2
n=23 Participants
57-83 minutes post consumption.
Post-test 3
n=23 Participants
93-119 minutes post consumption.
Vigor Symptoms (Profile of Mood State)
POMS Vigor - Placebo
3.78 units on a scale
Standard Deviation 4.36
3.57 units on a scale
Standard Deviation 4.00
3.52 units on a scale
Standard Deviation 3.44
3.65 units on a scale
Standard Deviation 3.68
Vigor Symptoms (Profile of Mood State)
POMS Vigor - Caffeine
3.91 units on a scale
Standard Deviation 3.66
3.91 units on a scale
Standard Deviation 3.99
4.00 units on a scale
Standard Deviation 3.92
4.26 units on a scale
Standard Deviation 3.29
Vigor Symptoms (Profile of Mood State)
POMS Vigor - Cocoa
3.65 units on a scale
Standard Deviation 4.01
3.74 units on a scale
Standard Deviation 3.45
4.00 units on a scale
Standard Deviation 3.84
3.70 units on a scale
Standard Deviation 3.30
Vigor Symptoms (Profile of Mood State)
POMS Vigor - Caffeinated Cocoa
4.09 units on a scale
Standard Deviation 4.43
4.48 units on a scale
Standard Deviation 4.28
4.04 units on a scale
Standard Deviation 4.03
4.17 units on a scale
Standard Deviation 3.87

Adverse Events

Caffeinated Cocoa

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cocoa

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cafeine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Patrick J. O'Connor

University of Georgia

Phone: 706-542-4382

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place