NCT04208256

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

4.8 years

First QC Date

December 19, 2019

Last Update Submit

June 4, 2025

Conditions

Keywords

pediatric obesityresting-state functional magnetic resonance imagingdisinhibited eating behavior

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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 Surplus

300ml fruit punch-flavored Glucola (75-gram\[g\], Azer Scientific) will be used as the energy surplus stimulus.

Dietary Supplement: Energy Stimulus

Interventions

Energy StimulusDIETARY_SUPPLEMENT

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.

Also known as: aspartame, Glucola, glucose
Energy NeutralEnergy Surplus

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • male or female
  • years-old
  • resident of Colorado

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Feeding BehaviorPediatric Obesity

Interventions

AspartameGlucolaGlucose

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsHexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 23, 2019

Study Start

December 30, 2019

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations