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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03203824
Other study ID # 5170184
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2017
Est. completion date June 1, 2018

Study information

Verified date June 2018
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
dark chocolate
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.
Other:
non dark chocolate
No dark chocolate will be given to this group during the procedures.

Locations

Country Name City State
United States Loma Linda U Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. change from baseline to during visualization of rest for one minute
Primary 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. change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
Secondary 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. change from baseline to during visualization of rest for one minute
Secondary 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. change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.
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