Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 12:33 AM
Study NCT ID:
NCT06310603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2023-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants and Outcomes of High vs. Low Ultra-processed Feeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Energy Intake', 'timeFrame': '1 year', 'description': '3-Day Food Logs will record caloric intake at various points'}, {'measure': 'Energy Expenditure', 'timeFrame': '1 year', 'description': 'Resting Metabolic Rate will be used to find resting energy expenditure and an accelerometer will measure expended energy through fitness, combined these will show energy expenditure'}, {'measure': 'Gut Microbiome Collection', 'timeFrame': '1 year', 'description': 'Stool kits administered for fecal collection will be used for gut microbiome collection'}], 'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': '1 year', 'description': 'Using a standard scale, body weight in kg will be assessed'}, {'measure': 'Body Composition', 'timeFrame': '1 year', 'description': 'Using Dual-energy X-ray absorptiometry(DXA), body composition will be assessed'}, {'measure': 'Fat Mass Percentage', 'timeFrame': '1 year', 'description': 'Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage will be assessed'}, {'measure': 'Fat-Free Mass Percentage', 'timeFrame': '1 year', 'description': 'Using Dual-energy X-ray absorptiometry(DXA), fat-free mass will be assessed'}], 'secondaryOutcomes': [{'measure': 'Triglyceride Levels', 'timeFrame': '1 year', 'description': 'Blood draw followed by a Piccolo scan will analyze Triglyceride levels in the blood'}, {'measure': 'Glucose Levels', 'timeFrame': '1 year', 'description': 'Blood draw followed by a Piccolo scan will analyze glucose in the blood'}, {'measure': 'Cholesterol Levels', 'timeFrame': '1 year', 'description': 'Blood draw followed by a Piccolo scan will analyze glucose in the blood'}, {'measure': 'HDL', 'timeFrame': '1 year', 'description': 'Blood draw followed by a Piccolo scan will analyze HDL in the blood'}, {'measure': 'LDL', 'timeFrame': '1 year', 'description': 'Piccolo scan will analyze LDL in the blood'}, {'measure': 'Alanine transaminase (ALT)', 'timeFrame': '1 year', 'description': 'Blood draw followed by a Piccolo scan will analyze ALT in the blood'}, {'measure': 'Aspartate transaminase (AST)', 'timeFrame': '1 year', 'description': 'Blood draw followed by a Piccolo scan will analyze AST in the blood'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Nutrition']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\\[s\\] it aims to answer are:\n\n• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.\n\nIf there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rural county resident\n* not meeting physical activity guidelines for adults\n* consuming a typical Western diet (rich in UPF)\n\nExclusion Criteria:\n\n* chronic diseases\n* tobacco, vape, or illicit drug use\n* overly active\n* already on a restrictive diet (e.g., keto, intermittent fasting)'}, 'identificationModule': {'nctId': 'NCT06310603', 'briefTitle': 'Determinants and Outcomes of High vs. Low Ultra-processed Feeding', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'Determinants and Outcomes of High vs. Low Ultra-processed Feeding', 'orgStudyIdInfo': {'id': 'IRB-23-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-Processed Food Group', 'interventionNames': ['Other: Low-Processed Food Diet']}, {'type': 'NO_INTERVENTION', 'label': 'Typical Diet Group'}], 'interventions': [{'name': 'Low-Processed Food Diet', 'type': 'OTHER', 'description': 'Participants that receive intervention will be instructed to eat a diet rich in unprocessed/minimally-processed foods, as described by the NOVA food classification system', 'armGroupLabels': ['Low-Processed Food Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74075', 'city': 'Stillwater', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Laboratory for Applied Nutrition and Exercise Science (LANES)', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}], 'overallOfficials': [{'name': 'Sam Emerson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}