OverweightNCT03364413
Brain's Response to Chocolate
An observational study of Overweight and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to test how the brain responds when individuals eat enjoyable foods such as chocolate. Eating certain foods can make one want to keep eating even when feeling full, caused by dopamine in the brain. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Chocolate
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 2 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- body mass index 20-30 kg/m2
- free of any major illness or disease
Who cannot join
- food allergies
- participation in a weight loss diet or exercise program
- pregnancy
- lactation
- metabolic illness or disease (diabetes, renal failure, thyroid illness, hypertension)
- eye illness or 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)
- take prescription medications except for oral contraceptives or antihyperlipidemia agents
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Behavioral Assessment of the Brain Response to Bioactive Food Components Using Electroretinography (Brain's Response to Chocolate)
The purpose of this study is to test how the brain responds when individuals eat enjoyable foods such as chocolate. Eating certain foods can make one want to keep eating even when feeling full, caused by dopamine in the brain. The researchers believe this dopamine response can be measured by looking at the individual's eye.
Read the detailed description
With obesity at an all-time high, understanding eating behavior beyond physical need is a priority. Food reinforcement is driven by central dopamine activity. However, objective measurement of brain dopamine-related behavioral events is hindered by the lack of non-invasive, accessible techniques that are amenable to testing in a "naturalistic" environment. The goal of this project is to develop a non-invasive, accessible methodology to measure dopaminergic responses to food in a natural setting. This research will use a novel, hand-held electroretinograph (ERG) that does not require eye dilation and uses a skin electrode to measure retinal dopamine activity. Previous work establishes that retinal dopamine activity can be used as a proxy for central dopamine function. The ability to assess both subjective behavioral variables and central dopaminergic responses simultaneously will provide an ideal approach for innovative studies of the control of eating behavior.
- Conditions
- Overweight, Obesity
- Being tested
- Chocolate
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChocolateOther
Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (milk, 70%, 85% and 90% cocoa).
| Study group | Role | What they receive |
|---|---|---|
| Chocolate | Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (milk, 70%, 85% and 90% cocoa). Receives: Other: Chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal dopamine response to oral stimuli
Electroretinograph beta wave amplitude will increase in response to increases in the amount of sugar in the chocolate
Measured: 30 minutes
Psychoactive Effects Questionnaire in response to oral stimuli
The number of positive responses on the Psychoactive Effects Questionnaire will increase in response to increases in the sugar content of the chocolate
Measured: 30 minutes
Secondary outcomes (1)
Scores on the Binge Eating Scale will correlate with the retinal dopamine and Psychoactive Effect Questionnaire responses
Individual changes in the retinal dopamine response and the number of positive responses on the Psychoactive Effects Questionnaire will correlate with individual scores on the Binge Eating Scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start17 Jan 2018
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Drexel University
- Responsible party
- Sponsor
- Investigators
- Shanon Casperson, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364413
- Sponsor's protocol ID
- GFHNRC217
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2017
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casperson SL, Lanza L, Albajri E, Nasser JA. Increasing Chocolate's Sugar Content Enhances Its Psychoactive Effects and Intake. Nutrients. 2019 Mar 12;11(3):596. doi: 10.3390/nu11030596.
PubMed 30870996
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Assessment of the Brain Response to Bioactive Food Components Using Electroretinography (Brain's Response to Chocolate)
- ClinicalTrials.gov ID
- NCT03364413
- Acronym / sponsor ID
- GFHNRC217
- Conditions
- Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Collaborators
- Drexel University
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test how the brain responds when individuals eat enjoyable foods such as chocolate. Eating certain foods can make one want to keep eating even when feeling full, caused by dopamine in the brain. The researchers believe this dopamine response can be measured by looking at the individual's eye.
Detailed description
With obesity at an all-time high, understanding eating behavior beyond physical need is a priority. Food reinforcement is driven by central dopamine activity. However, objective measurement of brain dopamine-related behavioral events is hindered by the lack of non-invasive, accessible techniques that are amenable to testing in a "naturalistic" environment. The goal of this project is to develop a non-invasive, accessible methodology to measure dopaminergic responses to food in a natural setting. This research will use a novel, hand-held electroretinograph (ERG) that does not require eye dilation and uses a skin electrode to measure retinal dopamine activity. Previous work establishes that retinal dopamine activity can be used as a proxy for central dopamine function. The ability to assess both subjective behavioral variables and central dopaminergic responses simultaneously will provide an ideal approach for innovative studies of the control of eating behavior.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chocolate | – | Other: ChocolateParticipants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (milk, 70%, 85% and 90% cocoa). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- body mass index 20-30 kg/m2
- free of any major illness or disease
Key exclusion criteria (8 listed)
- food allergies
- participation in a weight loss diet or exercise program
- pregnancy
- lactation
- metabolic illness or disease (diabetes, renal failure, thyroid illness, hypertension)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChocolateParticipants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (milk, 70%, 85% and 90% cocoa). | Other | Chocolate |
Primary outcome
Retinal dopamine response to oral stimuli
Time frame: 30 minutes
Electroretinograph beta wave amplitude will increase in response to increases in the amount of sugar in the chocolate
Psychoactive Effects Questionnaire in response to oral stimuli
Time frame: 30 minutes
The number of positive responses on the Psychoactive Effects Questionnaire will increase in response to increases in the sugar content of the chocolate
1 secondary outcome
Scores on the Binge Eating Scale will correlate with the retinal dopamine and Psychoactive Effect Questionnaire responses
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 30870996Casperson SL, Lanza L, Albajri E, Nasser JA. Increasing Chocolate's Sugar Content Enhances Its Psychoactive Effects and Intake. Nutrients. 2019 Mar 12;11(3):596. doi: 10.3390/nu11030596.
- Individual participant dataSharing planned: No
Related trials for Overweight
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingPhase 2
A Study to Evaluate Efficacy and Safety of BGM1812 Injection in Overweight or Obese Participants Without Diabetes
Overweight or Obese Participants Without Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanon Casperson, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal dopamine response to oral stimuli (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.