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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04037020
Other study ID # GFHNRC218
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 25, 2019
Est. completion date September 5, 2019

Study information

Verified date January 2022
Source USDA Grand Forks Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 5, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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%)).

Locations

Country Name City State
United States USDA Grand Forks Human Nutrition Research Center Grand Forks North Dakota

Sponsors (1)

Lead Sponsor Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal dopamine response to oral stimuli Electroretinograph b-wave amplitude will increase in response to increases in the amount of sugar in the chocolate. 30 minutes
Secondary Correlation between b-wave amplitude and PEQ scores The change in b-wave amplitude will positively correlate to Psychophysical Effects Questionnaire (PEQ) score changes. 30 minutes
Secondary Correlation between b-wave amplitude and habitual dietary intake 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. 30 minutes
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