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Food Intake and the Adolescent Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208256
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Dietary Supplement: Energy Stimulus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents With and Without Obesity
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025

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:
  • aspartame
  • Glucola
  • glucose

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:
  • aspartame
  • Glucola
  • glucose




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208256


Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Allison Shapiro, PhD    303-724-3733    allison.shapiro@cuanschutz.edu   
Principal Investigator: Allison Shapiro, PhD         
Sub-Investigator: Jason Tregellas, PhD         
Sub-Investigator: Susan Johnson, PhD         
Sub-Investigator: Marc Cornier, MD         
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04208256    
Other Study ID Numbers: 19-1171
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
pediatric obesity
resting-state functional magnetic resonance imaging
disinhibited eating behavior
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms