Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT04208256
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2019-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Intake and the Adolescent Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001218', 'term': 'Aspartame'}, {'id': 'C007853', 'term': 'Glucola'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2019-12-19', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain function', 'timeFrame': 'brain imaging visit 1 (study visit 1); 30 minutes', 'description': '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.'}, {'measure': 'Disinhibited eating behavior', 'timeFrame': 'study visit 2; 1.5 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric obesity', 'resting-state functional magnetic resonance imaging', 'disinhibited eating behavior'], 'conditions': ['Feeding Behavior', 'Brain', 'Adolescent']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female\n* 13-18 years-old\n* resident of Colorado\n\nExclusion Criteria:\n\n* weigh less than 88 pounds or have a BMI% rank of \\<10% for age and sex;\n* have a physician's diagnosis of metabolic syndrome or diabetes (Type 1 or 2);\n* have a physician's diagnosis of anorexia nervosa or bulimia nervosa;\n* currently taking anti-psychotic medications (not including anti-depressant or anti- anxiety medications);\n* have a non-MRI safe device (e.g. pacemaker or defibrillator) or metal in the body (e.g. metal pins, shrapnel);\n* experience symptoms of claustrophobia when in small or closed-off places;\n* are pregnant or plan to become pregnant"}, 'identificationModule': {'nctId': 'NCT04208256', 'acronym': 'ADOB', 'briefTitle': 'Food Intake and the Adolescent Brain', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'The Neural Underpinnings of Disinhibited Eating Behavior in Adolescents With and Without Obesity', 'orgStudyIdInfo': {'id': '19-1171'}, 'secondaryIdInfos': [{'id': 'K01DK120562', 'link': 'https://reporter.nih.gov/quickSearch/K01DK120562', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Energy Neutral', 'description': 'Bottled water (300 ml) with added fruit punch-flavored non-nutritive sweetener (aspartame) will be used as the energy neutral stimulus.', 'interventionNames': ['Dietary Supplement: Energy Stimulus']}, {'label': 'Energy Surplus', 'description': '300ml fruit punch-flavored Glucola (75-gram\\[g\\], Azer Scientific) will be used as the energy surplus stimulus.', 'interventionNames': ['Dietary Supplement: Energy Stimulus']}], 'interventions': [{'name': 'Energy Stimulus', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['aspartame', 'Glucola', 'glucose'], 'description': '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.', 'armGroupLabels': ['Energy Neutral', 'Energy Surplus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}