NCT03203824

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

June 26, 2017

Last Update Submit

June 20, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • EEG wave band activity with dark chocolate ingestion

    change from baseline to during visualization of rest for one minute

  • EEG wave band activity with dark chocolate ingestion

    change from visualization of rest for one minute and during visualization of usual vigorous exercise for one minute.

Study Arms (2)

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.

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.

Other: non dark chocolate

Interventions

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.

dark chocolate

No dark chocolate will be given to this group during the procedures.

non dark chocolate

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda U

Loma Linda, California, 92354, United States

Location

Study Officials

  • Georgia Hodgkin, EdD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 29, 2017

Study Start

September 5, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 25, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations