Energy Stimulus for Feeding Disorders in Adolescents

(ADOB Trial)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for boys and girls aged 13-18 living in Colorado. It's not suitable for those with claustrophobia, eating disorders like anorexia or bulimia, metal implants that aren't MRI-safe, very low body weight or BMI, metabolic syndrome or diabetes, those on antipsychotic meds, or who are pregnant.

Inclusion Criteria

Resident of Colorado

I am either male or female.

I am between 13 and 18 years old.

Exclusion Criteria

Are pregnant or plan to become pregnant

I am currently on medication for psychosis.

Have a non-MRI safe device (e.g. pacemaker or defibrillator) or metal in the body (e.g. metal pins, shrapnel)

Treatment Details

Interventions

• Energy Stimulus (Other)

Trial Overview The study investigates how the adolescent brain responds to excess energy (like overeating) using brain scans called functional magnetic resonance imaging (fMRI). It aims to understand the link between brain activity and overeating in teens with and without obesity.

Participant Groups

Group I: Energy Surplus Active Control 1 Intervention

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

Group II: Energy Neutral Placebo Group 1 Intervention

Bottled water (300 ml) with added fruit punch-flavored non-nutritive sweetener (aspartame) will be used as the energy neutral stimulus.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.