- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03364413
Brain's Response to Chocolate
December 1, 2023 updated by: USDA Grand Forks Human Nutrition Research Center
Behavioral Assessment of the Brain Response to Bioactive Food Components Using Electroretinography (Brain's Response to Chocolate)
The purpose of this study is to test how the brain responds when individuals eat enjoyable foods such as chocolate.
Eating certain foods can make one want to keep eating even when feeling full, caused by dopamine in the brain.
The researchers believe this dopamine response can be measured by looking at the individual's eye.
Study Overview
Detailed Description
With obesity at an all-time high, understanding eating behavior beyond physical need is a priority.
Food reinforcement is driven by central dopamine activity.
However, objective measurement of brain dopamine-related behavioral events is hindered by the lack of non-invasive, accessible techniques that are amenable to testing in a "naturalistic" environment.
The goal of this project is to develop a non-invasive, accessible methodology to measure dopaminergic responses to food in a natural setting.
This research will use a novel, hand-held electroretinograph (ERG) that does not require eye dilation and uses a skin electrode to measure retinal dopamine activity.
Previous work establishes that retinal dopamine activity can be used as a proxy for central dopamine function.
The ability to assess both subjective behavioral variables and central dopaminergic responses simultaneously will provide an ideal approach for innovative studies of the control of eating behavior.
Study Type
Observational
Enrollment (Actual)
20
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
-
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North Dakota
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Grand Forks, North Dakota, United States, 58203
- USDA Grand Forks Human Nutrition Research Center
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-
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
Inclusion Criteria:
- body mass index 20-30 kg/m2
- free of any major illness or disease
Exclusion Criteria:
- food allergies
- participation in a weight loss diet or exercise program
- pregnancy
- lactation
- metabolic illness or disease (diabetes, renal failure, thyroid illness, hypertension)
- eye illness or disease (narrow angle glaucoma, macular degeneration, retinal detachment, cataracts)
- psychiatric, neurological or eating disorders (schizophrenia, depression, Parkinson's Disease, Huntington's Disease, cerebral palsy, stroke, epilepsy, anorexia nervosa or bulimia nervosa)
- take prescription medications except for oral contraceptives or antihyperlipidemia agents
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chocolate
Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (milk, 70%, 85% and 90% cocoa).
|
Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (milk, 70%, 85% and 90% cocoa).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retinal dopamine response to oral stimuli
Time Frame: 30 minutes
|
Electroretinograph beta wave amplitude will increase in response to increases in the amount of sugar in the chocolate
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30 minutes
|
|
Psychoactive Effects Questionnaire in response to oral stimuli
Time Frame: 30 minutes
|
The number of positive responses on the Psychoactive Effects Questionnaire will increase in response to increases in the sugar content of the chocolate
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30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scores on the Binge Eating Scale will correlate with the retinal dopamine and Psychoactive Effect Questionnaire responses
Time Frame: 30 minutes
|
Individual changes in the retinal dopamine response and the number of positive responses on the Psychoactive Effects Questionnaire will correlate with individual scores on the Binge Eating Scale
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Shanon Casperson, PhD, USDA Grand Forks Human Nutrition Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 17, 2018
Primary Completion (Actual)
March 2, 2018
Study Completion (Actual)
March 2, 2018
Study Registration Dates
First Submitted
November 30, 2017
First Submitted That Met QC Criteria
November 30, 2017
First Posted (Actual)
December 6, 2017
Study Record Updates
Last Update Posted (Estimated)
December 8, 2023
Last Update Submitted That Met QC Criteria
December 1, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFHNRC217
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.
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