HealthyNCT03203824
The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals
A study testing dark chocolate and non dark chocolate in people with Healthy, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this graduate student study is to determine if ingestion of dark chocolate (70% cacao) will change brain frequencies between visualization at a state of rest and a state of exercise performance via electroencephalography (EEG) in vigorously active individuals. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- dark chocolate and non dark chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-45 years of age
- vigorously active individuals, based on the General Physical Activities defined by Level of Intensity guidelines, greater than 75 minutes per week
- enjoy dark chocolate
Who cannot join
- Caffeine, sedatives, or tranquilizers within 12 hours of study
- Creatine or other performance enhancing steroid supplementation within 24 hours of study
- Ginseng supplementation within 24 hours of study
- Barbiturates within at least 36 hours of study
- Currently taking antiepileptic medications
- Any allergies, colds or sinus infections day of the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this graduate student study is to determine if ingestion of dark chocolate (70% cacao) will change brain frequencies between visualization at a state of rest and a state of exercise performance via electroencephalography (EEG) in vigorously active individuals.
Read the detailed description
The procedures include: On day one, participants will fill out a dark chocolate Likert scale, physical activity assessment, and demographic questionnaire. Day two and three, on consecutive days will include, three EEG measurements will be recorded: 1) at baseline, 2) during visualization of rest for one minute, and 3) during visualization of usual vigorous exercise for one minute. The second day all three measurements will be recorded without dark chocolate (70% cacao). The third day all three measurements will be recorded again. Measurements 2 and 3 will be recorded savoring dark chocolate and after fully ingesting the dark chocolate respectively.
- Conditions
- Healthy
- Being tested
- dark chocolate, non dark chocolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dark chocolateDietary supplement
Participants will be provided Parliament dark chocolate (70% cocoa) from Redlands, CA. The Parliament chocolate is made with cacao and cane sugar. Each participant will be given half a piece (1.4 g) of dark chocolate to consume for this experiment over three minutes.
non dark chocolateOther
No dark chocolate will be given to this group during the procedures.
| Study group | Role | What they receive |
|---|---|---|
| dark chocolate | Experimental | Three EEG measurements will be recorded: 1) at baseline, 2) during visualization of rest for one minute, and 3) during visualization of usual vigorous exercise for one minute. Measurements 2 and 3 will be recorded savoring dark chocolate and after fully ingesting the dark chocolate respectively. Receives: Dietary Supplement: dark chocolate |
| non dark chocolate | Active comparator | three EEG measurements will be recorded: 1) at baseline, 2) during visualization of rest for one minute, and 3) during visualization of usual vigorous exercise for one minute. Receives: Other: non dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Wave Band Activity without dark chocolate ingestion
The EEG, electroencephalogram, is a test that detects abnormalities in the brain waves or the electrical activity of the brain. During the procedure, electrodes consisting of small metal discs with thin wires are pasted onto the scalp. The electrodes detect tiny electrical charges that result from the activity in the brain cells. EEG wave band activity will be recorded from 9 cerebral cortical scalp locations: F3, Fz, F4, C3, Cz, C4, P3, Pz, and P4 using the EEG B-Alert 10X System, Carlsbad CA. Each of the brain frequencies will be measured in 5 second increments. Data collection will last no longer than 2 hours for each session.
Measured: change from baseline to during visualization of rest for one minute
EEG Wave Band Activity without dark chocolate ingestion
The EEG, electroencephalogram, is a test that detects abnormalities in the brain waves or the electrical activity of the brain. During the procedure, electrodes consisting of small metal discs with thin wires are pasted onto the scalp. The electrodes detect tiny electrical charges that result from the activity in the brain cells. EEG wave band activity will be recorded from 9 cerebral cortical scalp locations: F3, Fz, F4, C3, Cz, C4, P3, Pz, and P4 using the EEG B-Alert 10X System, Carlsbad CA. Each of the brain frequencies will be measured in 5 second increments. Data collection will last no longer than 2 hours for each session.
Measured: change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
Secondary outcomes (2)
EEG wave band activity with dark chocolate ingestion
The EEG, electroencephalogram, is a test that detects abnormalities in the brain waves or the electrical activity of the brain. During the procedure, electrodes consisting of small metal discs with thin wires are pasted onto the scalp. The electrodes detect tiny electrical charges that result from the activity in the brain cells. EEG wave band activity will be recorded from 9 cerebral cortical scalp locations: F3, Fz, F4, C3, Cz, C4, P3, Pz, and P4 using the EEG B-Alert 10X System, Carlsbad CA. Each of the brain frequencies will be measured in 5 second increments. Data collection will last no longer than 2 hours for each session.
Measured: change from baseline to during visualization of rest for one minute
EEG wave band activity with dark chocolate ingestion
The EEG, electroencephalogram, is a test that detects abnormalities in the brain waves or the electrical activity of the brain. During the procedure, electrodes consisting of small metal discs with thin wires are pasted onto the scalp. The electrodes detect tiny electrical charges that result from the activity in the brain cells. EEG wave band activity will be recorded from 9 cerebral cortical scalp locations: F3, Fz, F4, C3, Cz, C4, P3, Pz, and P4 using the EEG B-Alert 10X System, Carlsbad CA. Each of the brain frequencies will be measured in 5 second increments. Data collection will last no longer than 2 hours for each session.
Measured: change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start5 Sep 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Hodgkin, EdD, Loma Linda University
- Investigators
- Georgia Hodgkin, EdD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203824
- Sponsor's protocol ID
- 5170184
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2017
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals
- ClinicalTrials.gov ID
- NCT03203824
- Acronym / sponsor ID
- 5170184
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this graduate student study is to determine if ingestion of dark chocolate (70% cacao) will change brain frequencies between visualization at a state of rest and a state of exercise performance via electroencephalography (EEG) in vigorously active individuals.
Detailed description
The procedures include: On day one, participants will fill out a dark chocolate Likert scale, physical activity assessment, and demographic questionnaire. Day two and three, on consecutive days will include, three EEG measurements will be recorded: 1) at baseline, 2) during visualization of rest for one minute, and 3) during visualization of usual vigorous exercise for one minute. The second day all three measurements will be recorded without dark chocolate (70% cacao). The third day all three measurements will be recorded again. Measurements 2 and 3 will be recorded savoring dark chocolate and after fully ingesting the dark chocolate respectively.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dark chocolate | Experimental | Dietary Supplement: dark chocolateThree EEG measurements will be recorded: 1) at baseline, 2) during visualization of rest for one minute, and 3) during visualization of usual vigorous exercise for one minute. Measurements 2 and 3 will be recorded savoring dark chocolate and after fully ingesting the dark chocolate respectively. |
| non dark chocolate | Active comparator | Other: non dark chocolatethree EEG measurements will be recorded: 1) at baseline, 2) during visualization of rest for one minute, and 3) during visualization of usual vigorous exercise for one minute. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 21-45 years of age
- vigorously active individuals, based on the General Physical Activities defined by Level of Intensity guidelines, greater than 75 minutes per week
- enjoy dark chocolate
Key exclusion criteria (6 listed)
- Caffeine, sedatives, or tranquilizers within 12 hours of study
- Creatine or other performance enhancing steroid supplementation within 24 hours of study
- Ginseng supplementation within 24 hours of study
- Barbiturates within at least 36 hours of study
- Currently taking antiepileptic medications
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 |
|---|---|---|
| dark chocolateParticipants will be provided Parliament dark chocolate (70% cocoa) from Redlands, CA. The Parliament chocolate is made with cacao and cane sugar. Each participant will be given half a piece (1.4 g) of dark chocolate to consume for this experiment over three minutes. | Dietary supplement | dark chocolate |
| non dark chocolateNo dark chocolate will be given to this group during the procedures. | Other | non dark chocolate |
Primary outcome
EEG Wave Band Activity without dark chocolate ingestion
Time frame: change from baseline to during visualization of rest for one minute
The EEG, electroencephalogram, is a test that detects abnormalities in the brain waves or the electrical activity of the brain. During the procedure, electrodes consisting of small metal discs with thin wires are pasted onto the scalp. The electrodes detect tiny electrical charges that result from the activity in the brain cells. EEG wave band activity will be recorded from 9 cerebral cortical scalp locations: F3, Fz, F4, C3, Cz, C4, P3, Pz, and P4 using the EEG B-Alert 10X System, Carlsbad CA. Each of the brain frequencies will be measured in 5 second increments. Data collection will last no longer than 2 hours for each session.
EEG Wave Band Activity without dark chocolate ingestion
Time frame: change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
The EEG, electroencephalogram, is a test that detects abnormalities in the brain waves or the electrical activity of the brain. During the procedure, electrodes consisting of small metal discs with thin wires are pasted onto the scalp. The electrodes detect tiny electrical charges that result from the activity in the brain cells. EEG wave band activity will be recorded from 9 cerebral cortical scalp locations: F3, Fz, F4, C3, Cz, C4, P3, Pz, and P4 using the EEG B-Alert 10X System, Carlsbad CA. Each of the brain frequencies will be measured in 5 second increments. Data collection will last no longer than 2 hours for each session.
2 secondary outcomes
EEG wave band activity with dark chocolate ingestion
Time frame: change from baseline to during visualization of rest for one minute
EEG wave band activity with dark chocolate ingestion
Time frame: change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Georgia Hodgkin, EdD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dark chocolate and non dark chocolate in people with Healthy, run by Loma Linda University 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 3 inclusion and 6 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EEG Wave Band Activity without dark chocolate ingestion (time frame: change from baseline to during visualization of rest for one minute). 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?
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; AzTrials last refreshed its copy on 7 Nov 2026.