The Chocolate Study 2.0

Sponsor

USDA Grand Forks Human Nutrition Research Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT04037020

Collaborator

(none)

Enrollment

Location

1.4

Actual Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Jul 25, 2019

Actual Primary Completion Date :

Sep 5, 2019

Actual Study Completion Date :

Sep 5, 2019

Arms and Interventions

Arm	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%)).

Arm

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

Primary Outcome Measures

Retinal dopamine response to oral stimuli [30 minutes]
Electroretinograph b-wave amplitude will increase in response to increases in the amount of sugar in the chocolate.

Secondary Outcome Measures

Correlation between b-wave amplitude and PEQ scores [30 minutes]
The change in b-wave amplitude will positively correlate to Psychophysical Effects Questionnaire (PEQ) score changes.
Correlation between b-wave amplitude and habitual dietary intake [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

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Shanon Casperson, PhD, USDA Grand Forks Human Nutrition Research Center

Study Documents (Full-Text)

Informed Consent Form - Jul 11, 2019

More Information

Publications

None provided.

Responsible Party:

Shanon Casperson, Research Biologist, USDA Grand Forks Human Nutrition Research Center

ClinicalTrials.gov Identifier:

NCT04037020

Other Study ID Numbers:

GFHNRC218

First Posted:

Jul 30, 2019

Last Update Posted:

Feb 2, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 2, 2022