- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04037020
The Chocolate Study 2.0
January 18, 2022 updated by: Shanon Casperson, USDA Grand Forks Human Nutrition Research Center
Assessment of Dopaminergic Neurotransmission in Response to Tasting Chocolate (The Chocolate Study 2.0)
The purpose of this study is to test how the brain responds when enjoyable foods such as chocolate are consumed.
The investigators know that eating certain types of foods can make an individual want to keep eating even when he or she is full.
The chemical in the brain that causes this is called dopamine.
The investigators can measure this response by looking at changes to how an individual's eye responds to light.
Study Overview
Detailed Description
The overall objective of this study is to determine dopamine (DA) neuromodulation (changes in b-wave amplitude as measured by electroretinography (ERG)) in response to consuming a highly reinforcing food (chocolate).
The investigators hypothesize that orosensory stimulation with chocolates with increasing sugar content will increase the beta wave (b-wave) amplitude and the increase in the b-wave amplitude will correlate with score changes on the Psychophysical Effects Questionnaire (PEQ).
This will be accomplished by testing different chocolates (extreme dark (90% cocoa), dark (70% cocoa), milk (38% cocoa), and white (0% cocoa)) on different days using 1.0 cd∙s/m2 flash luminance energy.
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 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
Inclusion Criteria:
- BMI 20-24.9 kg/m2
- ability to understand and sign the consent form
- availability of transportation (i.e., participants must be able to provide their own transportation to the Grand Forks Human Nutrition Research Center)
- be free of any major illness/disease
Exclusion Criteria:
- food allergies
- participation in a weight loss diet/exercise program
- pregnancy
- lactation
- metabolic illness/disease (diabetes, renal failure, thyroid illness, hypertension)
- eye illness/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)
- taking any type of prescription medication with the exception of oral contraceptives and 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
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chocolate
Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa.
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Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (extreme dark (90%), dark (70%), milk (38%), and white (0%)).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retinal dopamine response to oral stimuli
Time Frame: 30 minutes
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Electroretinograph b-wave amplitude will increase in response to increases in the amount of sugar in the chocolate.
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30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between b-wave amplitude and PEQ scores
Time Frame: 30 minutes
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The change in b-wave amplitude will positively correlate to Psychophysical Effects Questionnaire (PEQ) score changes.
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30 minutes
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Correlation between b-wave amplitude and habitual dietary intake
Time Frame: 30 minutes
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A preference for dark chocolate and/or a greater habitual fat intake will positively correlate with the retinal dopamine-mediated response to the dark chocolates (90% and 70% cocoa) and a preference for milk chocolate and/or a greater habitual added sugar will positively correlate with the retinal dopamine-mediated response to the milk and white chocolates.
Higher amounts of artificial sweetener intake will will positively correlate with the retinal dopamine-mediated response to the milk and white chocolates.
Greater habitual chocolate intake will positively correlate to changes in b-wave amplitude.
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30 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this 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)
July 25, 2019
Primary Completion (Actual)
September 5, 2019
Study Completion (Actual)
September 5, 2019
Study Registration Dates
First Submitted
July 25, 2019
First Submitted That Met QC Criteria
July 25, 2019
First Posted (Actual)
July 30, 2019
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
January 18, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- GFHNRC218
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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