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The Chocolate Study 2.0

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ClinicalTrials.gov Identifier: NCT04037020
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : February 2, 2022
Sponsor:
Information provided by (Responsible Party):
Shanon Casperson, USDA Grand Forks Human Nutrition Research Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Normal Weight Other: Chocolate

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 Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Assessment of Dopaminergic Neurotransmission in Response to Tasting Chocolate (The Chocolate Study 2.0)
Actual Study Start Date : July 25, 2019
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : September 5, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
Chocolate
Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa.
 Other: Chocolate
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%)).


Outcome Measures
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Primary Outcome Measures :
  1. Retinal dopamine response to oral stimuli [ Time Frame: 30 minutes ]
    Electroretinograph b-wave amplitude will increase in response to increases in the amount of sugar in the chocolate.


Secondary Outcome Measures :
  1. Correlation between b-wave amplitude and PEQ scores [ Time Frame: 30 minutes ]
    The change in b-wave amplitude will positively correlate to Psychophysical Effects Questionnaire (PEQ) score changes.

  2. Correlation between b-wave amplitude and habitual dietary intake [ Time Frame: 30 minutes ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037020


Locations
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United States, North Dakota
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58203
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
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Principal Investigator: Shanon Casperson, PhD USDA Grand Forks Human Nutrition Research Center
  Study Documents (Full-Text)

Documents provided by Shanon Casperson, USDA Grand Forks Human Nutrition Research Center:
Informed Consent Form  [PDF] July 11, 2019

More Information
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Responsible Party: Shanon Casperson, Research Biologist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT04037020    
Other Study ID Numbers: GFHNRC218
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No