Food Intake and the Adolescent Brain

Adolescent Clinical Trial

— ADOB  

Official title:

The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents With and Without Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208256
• Other study ID #: 19-1171
• Secondary ID: K01DK120562
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 resonance imaging to examine how the brain's response to excess energy is related to overeating in adolescents with and without obesity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• male or female

• 13-18 years-old

• resident of Colorado

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adolescent
• Brain
• Feeding Behavior

Intervention

Dietary Supplement:
• Energy Stimulus
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.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	brain imaging visit 1 (study visit 1); 30 minutes
Primary	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.	study visit 2; 1.5 hours