Feeding BehaviorADOBNCT04208256
Food Intake and the Adolescent Brain
An observational study of Feeding Behavior and Brain, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The brain plays an integral role in how and what people eat. However, the brain's contribution to overeating is not well understood during sensitive developmental periods such as adolescence, when excessive weight gain and obesity prevalence are a significant concern.The proposed study will use functional magnetic… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior, Brain, Adolescent
- What is being tested?
- Energy Stimulus
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2019to 30 Sep 2024
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents with severe obesity enrolled from a specialty care lifesstyle medicine clinic and from the surrounding community. Adolescents with healthy weight enrolled from primary care clinic and from teh surrounding community.
Who may be able to join
- male or female
- 13-18 years-old
- resident of Colorado
Who cannot join
- weigh less than 88 pounds or have a BMI% rank of <10% for age and sex;
- have a physician's diagnosis of metabolic syndrome or diabetes (Type 1 or 2);
- have a physician's diagnosis of anorexia nervosa or bulimia nervosa;
- currently taking anti-psychotic medications (not including anti-depressant or anti- anxiety medications);
- have a non-MRI safe device (e.g. pacemaker or defibrillator) or metal in the body (e.g. metal pins, shrapnel);
- experience symptoms of claustrophobia when in small or closed-off places;
- are pregnant or plan to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents With and Without Obesity
The brain plays an integral role in how and what people eat. However, the brain's contribution to overeating is not well understood during sensitive developmental periods such as adolescence, when excessive weight gain and obesity prevalence are a significant concern.The proposed study will use functional magnetic resonance imaging to examine how the brain's response to excess energy is related to overeating in adolescents with and without obesity.
- Conditions
- Feeding Behavior, Brain, Adolescent
- Being tested
- Energy Stimulus
- Keywords
- pediatric obesity, resting-state functional magnetic resonance imaging, disinhibited eating behavior
- Medical subject headings
- Feeding Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy StimulusDietary supplement
Also called aspartame, Glucola, glucose
Energy stimulus (energy surplus v. energy neutral) will be randomly assigned at the first brain imaging visit. At the second brain imaging visit, the participant will receive the alternate stimulus from what they received at the first brain imaging visit.
| Study group | Role | What they receive |
|---|---|---|
| Energy Neutral | Bottled water (300 ml) with added fruit punch-flavored non-nutritive sweetener (aspartame) will be used as the energy neutral stimulus. Receives: Dietary Supplement: Energy Stimulus | |
| Energy Surplus | 300ml fruit punch-flavored Glucola (75-gram[g], Azer Scientific) will be used as the energy surplus stimulus. Receives: Dietary Supplement: Energy Stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain function
Brain function will be quantified via the blood oxygen level-dependent (BOLD) signal in the hypothalamus, insula, anterior cingulate cortex, nucleus accumbens, amygdala, and superior and inferior frontal gyri, and connectivity between these brain regions.
Measured: brain imaging visit 1 (study visit 1); 30 minutes
Disinhibited eating behavior
Disinhibited eating behavior will be quantified via the kilocalories consumed during the test meal phase of the Eating in the Absence of Hunger laboratory protocol.
Measured: study visit 2; 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start30 Dec 2019
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208256
- Sponsor's protocol ID
- 19-1171
- Other IDs
- K01DK120562
- Acronym
- ADOB
- Status last verified
- Jun 2025
- First submitted
- 19 Dec 2019
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents With and Without Obesity
- ClinicalTrials.gov ID
- NCT04208256
- Acronym / sponsor ID
- ADOB / 19-1171
- Conditions
- Feeding Behavior, Brain, Adolescent
- Keywords
- pediatric obesity, resting-state functional magnetic resonance imaging, disinhibited eating behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Dec 2019 (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 brain plays an integral role in how and what people eat. However, the brain's contribution to overeating is not well understood during sensitive developmental periods such as adolescence, when excessive weight gain and obesity prevalence are a significant concern.The proposed study will use functional magnetic resonance imaging to examine how the brain's response to excess energy is related to overeating in adolescents with and without obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy Neutral | – | Dietary Supplement: Energy StimulusBottled water (300 ml) with added fruit punch-flavored non-nutritive sweetener (aspartame) will be used as the energy neutral stimulus. |
| Energy Surplus | – | Dietary Supplement: Energy Stimulus300ml fruit punch-flavored Glucola (75-gram[g], Azer Scientific) will be used as the energy surplus stimulus. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with severe obesity enrolled from a specialty care lifesstyle medicine clinic and from the surrounding community. Adolescents with healthy weight enrolled from primary care clinic and from teh surrounding community.
Key inclusion criteria (3 listed)
- male or female
- 13-18 years-old
- resident of Colorado
Key exclusion criteria (7 listed)
- weigh less than 88 pounds or have a BMI% rank of <10% for age and sex;
- have a physician's diagnosis of metabolic syndrome or diabetes (Type 1 or 2);
- have a physician's diagnosis of anorexia nervosa or bulimia nervosa;
- currently taking anti-psychotic medications (not including anti-depressant or anti- anxiety medications);
- have a non-MRI safe device (e.g. pacemaker or defibrillator) or metal in the body (e.g. metal pins, shrapnel);
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 |
|---|---|---|
| Energy StimulusAlso: aspartame, Glucola, glucoseEnergy stimulus (energy surplus v. energy neutral) will be randomly assigned at the first brain imaging visit. At the second brain imaging visit, the participant will receive the alternate stimulus from what they received at the first brain imaging visit. | Dietary supplement | Energy Neutral, Energy Surplus |
Primary outcome
Brain function
Time frame: brain imaging visit 1 (study visit 1); 30 minutes
Brain function will be quantified via the blood oxygen level-dependent (BOLD) signal in the hypothalamus, insula, anterior cingulate cortex, nucleus accumbens, amygdala, and superior and inferior frontal gyri, and connectivity between these brain regions.
Disinhibited eating behavior
Time frame: study visit 2; 1.5 hours
Disinhibited eating behavior will be quantified via the kilocalories consumed during the test meal phase of the Eating in the Absence of Hunger laboratory protocol.
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 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Feeding Behavior and Brain, run by University of Colorado, Denver 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 3 inclusion and 7 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 Jun 2025. 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?
Brain function (time frame: brain imaging visit 1 (study visit 1); 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?
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 Jun 2025.