- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203824
The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals
June 20, 2018 updated by: Georgia Hodgkin, EdD, Loma Linda University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Loma Linda, California, United States, 92354
- Loma Linda U
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dark chocolate
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.
|
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.
|
|
Active Comparator: non dark chocolate
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.
|
No dark chocolate will be given to this group during the procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
change from baseline to during visualization of rest for one minute
|
|
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.
|
change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG wave band activity with 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.
|
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.
|
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.
|
change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Georgia Hodgkin, EdD, Loma Linda University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2017
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
June 26, 2017
First Submitted That Met QC Criteria
June 27, 2017
First Posted (Actual)
June 29, 2017
Study Record Updates
Last Update Posted (Actual)
June 25, 2018
Last Update Submitted That Met QC Criteria
June 20, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 5170184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
RAGE BioRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on dark chocolate
-
Queen Margaret UniversityBarry CallebautCompletedBody WeightUnited Kingdom
-
San Diego State UniversityActive, not recruitingCardiovascular DiseasesUnited States
-
Universidad de AntioquiaTerminated
-
University of Roma La SapienzaCompleted
-
King Saud UniversityRecruitingCardiovascular Health During Prolonged SittingSaudi Arabia
-
University of LeipzigCompleted
-
Gregoire Wuerzner; MDRecruiting
-
University of the Incarnate WordCompleted
-
Universidade Federal FluminenseCompleted