The Chocolate Study 2.0

Normal Weight Clinical Trial

Official title:

Assessment of Dopaminergic Neurotransmission in Response to Tasting Chocolate (The Chocolate Study 2.0)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037020
• Other study ID #: GFHNRC218
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Normal Weight

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