Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-01 @ 12:50 PM
Study NCT ID:
NCT06025292
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2023-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Whole Body Protein Breakdown', 'timeFrame': '24 hours', 'description': 'Amount of protein broken down per unit of time.'}, {'measure': 'Whole Body Protein Flux', 'timeFrame': '24 hours', 'description': 'Amount of protein turnover per unit of time.'}, {'measure': 'Glucose Regulation and Homeostasis', 'timeFrame': '24 hours', 'description': 'Derived from continuous glucose monitor data.'}], 'primaryOutcomes': [{'measure': 'Muscle Protein Synthesis', 'timeFrame': '24 hours', 'description': 'Mixed muscle protein synthesis expressed as the fractional synthetic rate.'}, {'measure': 'Whole Body Protein Balance', 'timeFrame': '24 hours', 'description': 'Amount of net protein gained per unit of time.'}], 'secondaryOutcomes': [{'measure': 'Whole Body Protein Synthesis', 'timeFrame': '24 hours', 'description': 'Amount of protein produced per unit of time.'}, {'measure': '24-hour Mean Glucose', 'timeFrame': '24 hours', 'description': 'Derived from continous glucose monitor data.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lean pork', 'Muscle Protein Synthesis', 'Protein', 'Plant-Based'], 'conditions': ['Hyperglycaemia (Non Diabetic)', 'Prediabetes']}, 'descriptionModule': {'briefSummary': 'We will be directly comparing a high-quality protein diet composed primarily of lean pork loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with prediabetes on muscle and whole-body protein turnover and glucose regulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Males and females ages 40-65 years.\n* 2\\. BMI 25 to ≤40 kg/m2 (or body fat % ≥25% in males or ≥36% in females)\n* 3\\. Capable of providing informed consent.\n* 4\\. COVID-19 negative and/or asymptomatic.\n* 5\\. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 4-day study meal period\n* 6\\. HbA1c: 5.7-6.4% or fasting glucose 100-125 mg/dL\n\nExclusion Criteria:\n\n* 1\\. Participant who does not/will not eat animal protein sources.\n* 2\\. Allergy to wheat, soy, or common ingredients in plant-based protein products.\n* 3\\. Body mass index \\<25 kg/m2 or \\>40 kg/m2.\n* 4\\. Hemoglobin \\<10g/dL at screening.\n* 5\\. Platelets \\<150,000/uL at screening.\n* 6\\. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.\n* 7\\. History of gastrointestinal bypass/reduction surgery.\n* 8\\. Pregnant or lactating individuals.\n* 9\\. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)\n* 10\\. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.\n* 11\\. Currently using prescription blood thinning medications.\n* 12\\. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).\n* 13\\. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3 and Visit 7.\n* 14\\. Unwilling to avoid using protein or amino-acid supplements during participation.\n* 15\\. Unwilling to fast overnight.\n* 16\\. Unwilling to avoid alcohol, marijuana and CBD products for the four study days.\n* 17\\. Participants on glucagon-like-peptide-1 receptor agonist (GLP-1-RA) medications for \\<1 month or with less than one treatment dose (injection) every two weeks"}, 'identificationModule': {'nctId': 'NCT06025292', 'acronym': 'PORK', 'briefTitle': 'Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults', 'orgStudyIdInfo': {'id': '276210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Quality Protein Intake - Lean Pork', 'description': "Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from lean pork.", 'interventionNames': ['Other: Lean Pork vs Plant-Based Protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Quality Protein Intake - Plant-Based', 'description': "Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from plant-based protein (ie impossible burger, black bean burger, soy, etc).", 'interventionNames': ['Other: Lean Pork vs Plant-Based Protein']}], 'interventions': [{'name': 'Lean Pork vs Plant-Based Protein', 'type': 'OTHER', 'description': 'Participants will eat prepared study meals for three days that have either protein sourced from lean pork or plant-based sources.', 'armGroupLabels': ['High Quality Protein Intake - Lean Pork', 'Low Quality Protein Intake - Plant-Based']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David D Church, PhD', 'role': 'CONTACT', 'email': 'dchurch@uams.edu'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'centralContacts': [{'name': 'David Church, PhD', 'role': 'CONTACT', 'email': 'dchurch@uams.edu', 'phone': '501-526-5769'}, {'name': 'Amanda Gwin, PA-C', 'role': 'CONTACT', 'email': 'algwin@uams.edu', 'phone': '5018380096'}], 'overallOfficials': [{'name': 'David Church, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Pork Board', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}