Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-04 @ 5:08 PM
Study NCT ID:
NCT03175003
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2017-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a New Food Product in Metabolically at Risk Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Products will look and taste similar, and will be provided in coded packaging'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind, controlled, 4 parallel arm design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2017-05-31', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Microvascular Function', 'timeFrame': 'Compare change in baseline and 4 weeks', 'description': 'Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values'}], 'secondaryOutcomes': [{'measure': 'Change in Metabolome', 'timeFrame': 'Compare change in baseline and 4 weeks', 'description': 'Measured with Nuclear Magnetic Resonance (NMR)'}, {'measure': 'Change in Lipidome', 'timeFrame': 'Compare change in baseline and 4 weeks', 'description': 'Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry'}, {'measure': 'Change in Inflammatory Markers', 'timeFrame': 'Compare change in baseline and 4 weeks', 'description': 'Measured by immunoassay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Risk Factor', 'Inflammation', 'Micronutrient Deficiency']}, 'descriptionModule': {'briefSummary': 'The current study conducted will lend toward the optimization of the development of a food product that will promote a shift towards improved metabolic health. Specifically, this trial will determine the optimal level of protein needed to elicit positive changes in markers of inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular function, and the relationship of these changes to the metabolome in school aged children (9 - 13 years of age).', 'detailedDescription': "Each participant will be asked to participate in a screening and 2 study intervention visits. Each intervention visit will include anthropometric measures, complete the education component, vascular function tests, and a blood draw and spot urine. The screening visit will confirm the child's eligibility for study enrollment and will serve to acclimate the child to the vascular function, and physical activity measurements. The remaining 2 visits will be scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical activity monitor, which in addition to tracking physical activity, will also be used to incorporate a nutrition education program. The parent/guardian will be asked to help with providing the child the daily food product and to help their child fill out the compliance log. Volunteers will also be sought for stool and saliva collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female 9-13 years old\n* Subject is willing and able to comply with the study protocols\n* Subject is willing to consume the test products\n* Access to a smart phone or tablet at least 1x / week; and willing to download a free applications associated with the study\n\nExclusion Criteria:\n\n* Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten\n* Under current medical supervision\n* Tanner Score = 4\n* Non-English speaking\n* Current participation in a daily exercise routine of moderate or high intensity\n* Self-reported presence of disease, a history of serious illness, or who are currently under acute medical care.\n* Currently taking prescription drugs or supplements\n* Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.\n* Self-reported malabsorption or gastrointestinal issues\n* Current enrollee in a clinical research study.'}, 'identificationModule': {'nctId': 'NCT03175003', 'briefTitle': 'Assessment of a New Food Product in Metabolically at Risk Children', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children', 'orgStudyIdInfo': {'id': '1009239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Food Product 1', 'description': 'Macronutrient similar to experimental, micronutrient lower than experimental', 'interventionNames': ['Other: Food Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Food Product 2', 'description': 'Macronutrient lower than experimental, micronutrient similar to experimental', 'interventionNames': ['Other: Food Product']}, {'type': 'EXPERIMENTAL', 'label': 'Food Product 3', 'description': 'Experimental 1', 'interventionNames': ['Other: Food Product']}, {'type': 'EXPERIMENTAL', 'label': 'Food Product 4', 'description': 'Experimental 2', 'interventionNames': ['Other: Food Product']}], 'interventions': [{'name': 'Food Product', 'type': 'OTHER', 'description': 'Each food product will provide similar calories, but a different micro- and macro-nutrient composition', 'armGroupLabels': ['Food Product 1', 'Food Product 2', 'Food Product 3', 'Food Product 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Department of Nutrition', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Carl L Keen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}