Mental FatigueNCT01651793

Effect of Phytochemicals From Theobroma Cacao on Mental Energy

A study testing Caffeinated cocoa, Cocoa and Caffeine in people with Mental Fatigue, run by University of Georgia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 34 yearsHealthy volunteers can take part
Conditions the study is for: Mental Fatigue
What is being tested?: Caffeinated cocoa, Cocoa and Caffeine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 34 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Georgia
Athens, Georgia, 30602

Other trials in United States

About this study

Read the 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.

Conditions: Mental Fatigue
Being tested: Caffeinated cocoa, Cocoa, Caffeine, Placebo
Keywords: cacao, theobromine, flavanols, caffeine, sustained attention, vigilance, vigor, vitality, energy, fatigue
Medical subject headings: Mental Fatigue, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Caffeinated cocoaOther
70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
CocoaOther
21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
CaffeineOther
473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener
PlaceboOther
473 ml of brewed water, caramel coloring and one packet Truvia sweetener

Study groups in NCT01651793
Study group	Role	What they receive
Caffeinated cocoa	Active comparator	High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Receives: Other: Caffeinated cocoa
Cocoa	Active comparator	High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle Receives: Other: Cocoa
Caffeine	Active comparator	Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle Receives: Other: Caffeine
Placebo	Placebo comparator	No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: baseline, post 60, post 90, post 120

Secondary outcomes (1)

Vigor Symptoms (Profile of Mood State)
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.
Measured: Pre and 90, 120 and 160 minutes post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jun 2014

First posted27 Jul 2012 (estimated)
Study startJul 2012
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mental FatigueStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01651793
Sponsor's protocol ID: Study of cocoa-like beverages
Status last verified: Jun 2018
First submitted: 25 Jul 2012
Last updated: 25 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: IPD will be kept securely at the University of Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog

All Mental Fatigue trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Phytochemicals From Theobroma Cacao on Mental Energy
ClinicalTrials.gov ID: NCT01651793
Acronym / sponsor ID: Study of cocoa-like beverages
Conditions: Mental Fatigue
Keywords: cacao, theobromine, flavanols, caffeine, sustained attention, vigilance, vigor, vitality
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of GeorgiaUniversity, hospital or other
Collaborators: The Hershey Company
Study start: Jul 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 27 Jul 2012 (estimated)
Results: Posted 25 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Caffeinated cocoa	Active comparator	Other: Caffeinated cocoaHigh flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle
Cocoa	Active comparator	Other: CocoaHigh flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle
Caffeine	Active comparator	Other: CaffeineLow flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle
Placebo	Placebo comparator	Other: PlaceboNo flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle

Who may qualify

Ages: 18 to 34 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

Pregnant
GI tract disorder
Psychoactive medication use
Daily consumption of > 200 mg caffeine
Body mass index > 30

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Caffeinated cocoa70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener	Other	Caffeinated cocoa
Cocoa21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener	Other	Cocoa
Caffeine473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener	Other	Caffeine
Placebo473 ml of brewed water, caramel coloring and one packet Truvia sweetener	Other	Placebo

Primary outcome

Correct Responses on Serial 7 Subtraction Task
Time frame: 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.
Performance on Bakan Task
Time frame: 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.

1 secondary outcome

Vigor Symptoms (Profile of Mood State)
Time frame: Pre and 90, 120 and 160 minutes post intervention

Results and safety

Results posted to the registry on 25 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caffeinated Cocoa, Cocoa, Caffeine, Placebo	6	6
Cocoa, Caffeine, Placebo, Caffeinated Cocoa	6	6
Caffeine, Placebo, Caffeinated Cocoa, Cocoa	6	6
Placebo, Caffeinated Cocoa, Cocoa, Caffeine	6	5

Primary outcome: Correct Responses on Serial 7 Subtraction Task

Time frame: Pre and 30, 60 and 120 minutes post intervention. Mean (Standard Deviation). Unit: Correct responses

Measure	Pre-test n = 23	Post-test 1 n = 23	Post-test 2 n = 23	Post-test 3 n = 23
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)

Pre-test: p = 0.05, ANCOVA

Primary outcome: Performance on Bakan Task

Time frame: baseline, post 60, post 90, post 120. Mean (Standard Deviation). Unit: units on a scale

Measure	Pre-test n = 23	Post-test 1 n = 23	Post-test 2 n = 23	Post-test 3 n = 23
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)

1 secondary outcome is reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Caffeinated Cocoa	0 of 23 (0%)	0 of 23 (0%)	Not reported
Cocoa	0 of 23 (0%)	0 of 23 (0%)	Not reported
Cafeine	0 of 23 (0%)	0 of 23 (0%)	Not reported
Placebo	0 of 23 (0%)	0 of 23 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD will be kept securely at the University of Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu).

Related trials for Mental Fatigue

Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick O'Connor, PhD principal investigator

University of Georgia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Caffeinated cocoa, Cocoa and Caffeine in people with Mental Fatigue, run by University of Georgia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correct Responses on Serial 7 Subtraction Task (time frame: Pre and 30, 60 and 120 minutes post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01651793.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.