Food Intake and the Adolescent Brain (ADOB)

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent; Feeding Behavior; Brain
• Intervention / Treatment: Dietary supplement: Energy Stimulus

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Allison Shapiro, PhD; Phone Number: 303-724-3733; Email: allison.shapiro@cuanschutz.edu
      • Principal Investigator: Allison Shapiro, PhD
      • Sub-Investigator: Jason Tregellas, PhD
      • Sub-Investigator: Susan Johnson, PhD
      • Sub-Investigator: Marc Cornier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Energy Neutral; Bottled water (300 ml) with added fruit punch-flavored non-nutritive sweetener (aspartame) will be used as the energy neutral stimulus.	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.; Other Names: glucose; aspartame; Glucola
Active Comparator: Energy Surplus; 300ml fruit punch-flavored Glucola (75-gram[g], Azer Scientific) will be used as the energy surplus stimulus.	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.; Other Names: glucose; aspartame; Glucola

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pediatric obesity; resting-state functional magnetic resonance imaging; disinhibited eating behavior
• Other Study ID Numbers: 19-1171; K01DK120562 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No