Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-01 @ 2:38 AM
Study NCT ID:
NCT03994367
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Animal and Plant Proteins and Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-04-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-06-20', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour plasma glucose concentration', 'timeFrame': 'up to 12 weeks after the intervention'}, {'measure': 'Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure', 'timeFrame': 'up to 12 weeks after the intervention'}], 'secondaryOutcomes': [{'measure': 'Postprandial plasma glucose concentration', 'timeFrame': 'up to 12 weeks after the intervention'}, {'measure': 'mTOR signaling (phospho-S6 content) in circulating monocytes', 'timeFrame': 'up to 12 weeks after the intervention'}, {'measure': 'Endothelial function, assessed as reactive hyperemia index', 'timeFrame': 'up to 12 weeks after the intervention'}, {'measure': 'Postprandial plasma insulin concentration', 'timeFrame': 'up to 12 weeks after the intervention'}, {'measure': 'Postprandial plasma amino acid concentration', 'timeFrame': 'up to 12 weeks after the intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Protein', 'Metabolism', 'Diet'], 'conditions': ['Metabolic Syndrome', 'Metabolic Syndrome, Protection Against', 'Glucose Metabolism Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this proposal is to determine the effect of a high protein diet in which the increase in protein intake is derived from different sources (animal vs plant and protein-rich whole foods vs protein isolates) on: i) liver and muscle insulin sensitivity; ii) the metabolic response to a meal, and iii) 24-h plasma concentration profiles of glucose, glucoregulatory hormones, and protein-derived metabolites purported to cause metabolic dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: ≥21 and ≤70 years;\n* BMI: \\>24.5 and \\<32.5 kg/m2;\n* habitual protein intake \\<0.9 g/kg/day (assessed on 2 weekdays and 2 weekend days by using the HealthWatch 360 app); and\n* weight stable (i.e., ≤3% change) and untrained (≤150 min of structured exercise/week) for at least 2 months before entering the study.\n\nExclusion Criteria:\n\n* prediabetes or type 2 diabetes;\n* evidence of chronic kidney disease by medical history or laboratory tests (glomerular filtration rate \\<60 ml/min/1.73 m2 or an albumin to creatinine ratio in urine ≥30 mg/g);\n* vegetarians or vegans;\n* intolerance or allergies to ingredients in the metabolic meal or intervention diet;\n* take dietary supplements (e.g., pre- and probiotics, fiber, fish oil) or medications known to affect our study outcomes;\n* received antibiotic or antifungal treatment (which affect the microbiome and therefore microbial metabolite production) 2 months before entering the study;\n* consume tobacco products or excessive alcohol (women: \\>14 drinks/week; men: \\>21 drinks/week);\n* evidence of significant organ system dysfunction or diseases (e.g., cirrhosis), and\n* unwilling or unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03994367', 'acronym': 'HP', 'briefTitle': 'Animal and Plant Proteins and Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Animal and Plant Proteins and Glucose Metabolism', 'orgStudyIdInfo': {'id': '2097498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard protein (control)'}, {'type': 'EXPERIMENTAL', 'label': 'High animal protein isolate', 'interventionNames': ['Other: High animal protein isolate']}, {'type': 'EXPERIMENTAL', 'label': 'High animal protein whole food', 'interventionNames': ['Other: High animal protein whole food']}, {'type': 'EXPERIMENTAL', 'label': 'High plant protein isolate', 'interventionNames': ['Other: High plant protein isolate']}, {'type': 'EXPERIMENTAL', 'label': 'High plant protein whole food', 'interventionNames': ['Other: High plant protein whole food']}], 'interventions': [{'name': 'High animal protein isolate', 'type': 'OTHER', 'description': 'Increased dietary protein content from animal protein isolates', 'armGroupLabels': ['High animal protein isolate']}, {'name': 'High animal protein whole food', 'type': 'OTHER', 'description': 'Increased dietary protein content from animal protein whole food', 'armGroupLabels': ['High animal protein whole food']}, {'name': 'High plant protein isolate', 'type': 'OTHER', 'description': 'Increased dietary protein content from plant protein isolates', 'armGroupLabels': ['High plant protein isolate']}, {'name': 'High plant protein whole food', 'type': 'OTHER', 'description': 'Increased dietary protein content from animal protein whole food', 'armGroupLabels': ['High plant protein whole food']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'BETTINA MITTENDORFER', 'role': 'CONTACT', 'email': 'b.mittendorfer@missouri.edu', 'phone': '618-610-3465'}, {'role': 'CONTACT', 'email': 'b.mittendorfer@missouri.edu', 'phoneExt': 'MITTENDORFER'}], 'facility': 'University of Missouri School of Medicine', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'centralContacts': [{'name': 'BETTINA MITTENDORFER', 'role': 'CONTACT', 'email': 'b.mittendorfer@missouri.edu', 'phone': '618-610-3465'}], 'overallOfficials': [{'name': 'Bettina Mittendorfer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Dean for Research', 'investigatorFullName': 'Bettina Mittendorfer', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}