Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT03112161
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2017-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Energy Imbalance on Food Intake Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neuronal response to food vs. nonfood objects in fasted vs. fed states', 'timeFrame': 'Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)', 'description': 'Change in neuronal response to food vs. nonfood objects in the overfed and underfed feeding periods as compared to the eucaloric period between fasted and fed states in obese-prone as compared to obese-resistant individuals.'}], 'secondaryOutcomes': [{'measure': 'Change in appetite ratings', 'timeFrame': 'At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.', 'description': 'Change in appetite ratings via visual analog scale (VAS; 0-100) before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.'}, {'measure': 'Change in food cravings', 'timeFrame': 'At baseline and both before and after a meal on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding).', 'description': 'Change in food cravings (questionnaire) before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.'}, {'measure': 'Change in leptin levels', 'timeFrame': 'At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.', 'description': 'Change in blood leptin levels before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.'}, {'measure': 'Change in ghrelin levels', 'timeFrame': 'At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.', 'description': 'Change in blood ghrelin levels before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.'}, {'measure': 'Change in PYY levels', 'timeFrame': 'At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.', 'description': 'Change in blood Peptide YY (PYY) levels before vs. after a meal in the overfeeding and underfeeding periods compared to the eucaloric feeding periods between obese-resistant and obese-prone individuals.'}, {'measure': 'Change in neuronal response to hedonic vs. basic food images', 'timeFrame': 'Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)', 'description': 'Change in neuronal response to hedonic vs. basic food images in the overfed and underfed feeding periods as compared to the eucaloric period between fasted and fed states in obese-prone as compared to obese-resistant individuals.'}, {'measure': 'Change in body weight', 'timeFrame': 'Baseline and every 6 months for up to 5 years after study participation.', 'description': 'Change in body weight from baseline for up to 5 years in obese-resistant and obese-prone individuals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study will determine whether changes in energy balance alter regional neuronal activation of brain regions associated with food intake in individuals screened to be either resistant or prone to obesity. Specifically, it will determine whether foods of "hedonic" value elicit changes in regional neuronal activity in the fasted and fed state in "obese-resistant" and "obese-prone" men and women in varying states of energy balance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn the obese-prone group:\n\n* BMI between 20-30\n* Report at least one obese first-degree relative\n* Self-describe as "struggling" with weight\n* Weight-stable for at least 3 months prior to study participation\n\nIn the obese-resistant group:\n\n* BMI between 17-25\n* Report no obese first-degree relatives\n* Self-describe as "naturally thin" and have never been overweight\n* Overall weight stability\n\nExclusion Criteria:\n\n* Significant medical or psychiatric disease\n* History of eating disorder\n* Left handed\n* Unable to complete an MRI scan (e.g., metal in body, claustrophobic)'}, 'identificationModule': {'nctId': 'NCT03112161', 'briefTitle': 'The Effects of Energy Imbalance on Food Intake Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'The Effects of Energy Imbalance on Food Intake Behaviors', 'orgStudyIdInfo': {'id': '05-0067'}, 'secondaryIdInfos': [{'id': 'R01DK072174', 'link': 'https://reporter.nih.gov/quickSearch/R01DK072174', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eucaloric', 'description': 'Participants will consume a eucaloric diet with a macronutrient composition of 20% protein, 30% fat and 50% carbohydrate for 4 days (Eucaloric Feeding Period). The caloric value of the diet will be calculated based on lean body mass plus an activity factor to ensure energy and macronutrient balance.', 'interventionNames': ['Other: Eucaloric Feeding Period']}, {'type': 'EXPERIMENTAL', 'label': 'Overfed', 'description': 'Following 3 days of eucaloric feeding, participants will complete a 1-day overfeeding period (Overfeeding Feeding Period), during which their diet will have a daily energy value of 40% greater than the eucaloric diet (Eucaloric Arm), although the macronutrient composition will remain the same (20% protein, 30% fat, 50% carbohydrate).', 'interventionNames': ['Other: Overfeeding Feeding Period']}, {'type': 'EXPERIMENTAL', 'label': 'Underfed', 'description': 'Following 3 days of eucaloric feeding, participants will complete a 1-day underfeeding period (Underfeeding Feeding Period), during which their diet will have a daily energy value of 40% less than the eucaloric diet (Eucaloric Arm), although the macronutrient composition will remain the same (20% protein, 30% fat, 50% carbohydrate).', 'interventionNames': ['Other: Underfeeding Feeding Period']}], 'interventions': [{'name': 'Eucaloric Feeding Period', 'type': 'OTHER', 'armGroupLabels': ['Eucaloric']}, {'name': 'Overfeeding Feeding Period', 'type': 'OTHER', 'armGroupLabels': ['Overfed']}, {'name': 'Underfeeding Feeding Period', 'type': 'OTHER', 'armGroupLabels': ['Underfed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Jason Tregellas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Marc-Andre Cornier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, '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'}}}}