Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-01 @ 5:09 AM
Study NCT ID:
NCT05230433
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2022-01-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High-fat Meal Challenge in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jen@htnutrition.com', 'phone': '6036505250', 'title': 'Jennifer Meijer', 'organization': 'Happy Trails Nutrition'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from signing the consent document to 2 weeks post the high-fat challenge study visit. Participants concluded the study at this timepoint.', 'description': 'No difference', 'eventGroups': [{'id': 'EG000', 'title': 'High-fat Metabolic Challenge', 'description': 'All participants consumed the high-fat challenge', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Palatability of the High Fat Agent.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High-fat Metabolic Challenge', 'description': 'All participants consumed the high-fat challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000'], 'paramType': 'Percent Consumed', 'ciNumSides': 'TWO_SIDED', 'paramValue': '86', 'pValueComment': 'p-value was not adjusted for multiple comparisons', 'groupDescription': 'High fat agents were weighed pre- and post- providing the shake to the participant. All containers were tared to take into account straw, lid, and glass weight. Percentage of high-fat challenge consumed was calculated by post-shake weight / pre-shake weight. 13 out of 15 partcipants drank \\>75% of the shake.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 minutes', 'description': 'Determine the number of participants that complete at least 75% of the shake (by weight).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BMI Percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High-fat Metabolic Challenge', 'description': 'All participants consumed a high-fat agent at the second study visit. The shake was be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '24', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000'], 'pValueComment': 'This p-value is not adjusted for multiple comparisons.', 'groupDescription': 'Fold change from 60 to 180 minutes of average medium chain acylcarnitine was calculated for each participant. Pearson correlation between BMI percentile and fold change was calculated.', 'statisticalMethod': 'Pearson Correlation', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'No test vs. control groups.', 'otherAnalysisDescription': 'Pearson Correlation between both secondary outcomes reported: BMI percentile and fold change between acylcarnitine at 60 minutes and 180 minutes post the high fat challenge.'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'BMI percentile calculated for each participant. Average and standard deviations were reported.', 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medium Chain Acylcarnitine Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High-fat Metabolic Challenge', 'description': 'All participants consumed a high-fat agent at the second study visit. The shake was be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.'}], 'classes': [{'title': 'Average MC acylcarnitine at 60 minutes', 'categories': [{'measurements': [{'value': '0.055', 'spread': '0.015', 'groupId': 'OG000'}]}]}, {'title': 'Average MC acylcarnitine at 180 minutes', 'categories': [{'measurements': [{'value': '0.061', 'spread': '0.014', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 and 180 minutes post consumption of high fat shake', 'description': 'Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.', 'unitOfMeasure': 'mircoM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High-fat Metabolic Challenge', 'description': 'All participants consumed a high-fat agent at the second study visit. The shake was be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.902', 'spread': '0.021', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 and 180 minutes post consumption of high fat shake', 'description': 'Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-fat Metabolic Challenge', 'description': 'All participants consumed a high-fat agent at the second study visit. The shake was be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Enrollment was completed in September 2022 (n=15). Recruitment followed D-H IRB approval. Adolescents (8-17 years) were recruited through the Children's Hospital at Dartmouth Hitchcock (assisted by Dr. Susanne Tanski), the Weight and Wellness Center (assisted by Dr. Auden McClure), and, as needed, through the community. Flyers have been developed by DHMC marketing.", 'preAssignmentDetails': 'No pre-assignment occurred.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'High-fat Metabolic Challenge', 'description': 'Participants will consume a high-fat agent one time, at the second study visit.\n\nHigh-fat Challenge: The shake will be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'spread': '6.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-28', 'size': 1272888, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-10T09:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2022-01-06', 'resultsFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-07-17', 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Palatability of the High Fat Agent.', 'timeFrame': '10 minutes', 'description': 'Determine the number of participants that complete at least 75% of the shake (by weight).'}], 'secondaryOutcomes': [{'measure': 'BMI Percentile', 'timeFrame': 'At baseline', 'description': 'BMI percentile calculated for each participant. Average and standard deviations were reported.'}, {'measure': 'Medium Chain Acylcarnitine Concentration', 'timeFrame': '60 and 180 minutes post consumption of high fat shake', 'description': 'Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.'}, {'measure': 'Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes.', 'timeFrame': '60 and 180 minutes post consumption of high fat shake', 'description': 'Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Obesity', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The objective is to determine if how physical fitness, measured using a treadmill maximal oxidative capacity test, is associated with the capacity to metabolize a high-fat meal in pediatrics (ages 8-17 years). Ability to metabolize the meal will be assessed by profiling mitochondrial and extra-mitochondrial fatty acid metabolites. The investigators will test if fatty acid oxidation mediates the relationship between fitness and markers of metabolic health, such as insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages 8-17 years with a BMI-percentile ≥ 5th.\n\nExclusion Criteria:\n\n* Previous diagnosis of type 1 or 2 diabetes.\n* Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).\n* Evidence of inherited disorders of lipid metabolism.\n* Inability to participant in the maximal aerobic capacity test on the treadmill.\n* Allergies to palm oils or protein types within high-fat challenge, such as lactose and soy.\n* Individuals who cannot speak and/or write in English.'}, 'identificationModule': {'nctId': 'NCT05230433', 'briefTitle': 'High-fat Meal Challenge in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Implications of Insulin Resistance and Cardiorespiratory Fitness in the Metabolic Response to a High-fat Meal Challenge in Pediatrics', 'orgStudyIdInfo': {'id': 'STUDY02001316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-fat Metabolic Challenge', 'description': 'Participants will consume a high-fat agent one time, at the second study visit.', 'interventionNames': ['Dietary Supplement: High-fat Challenge']}], 'interventions': [{'name': 'High-fat Challenge', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The shake will be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.', 'armGroupLabels': ['High-fat Metabolic Challenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Health', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Scientist', 'investigatorFullName': 'Jennifer L. Meijer', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}