Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 4:33 PM
Study NCT ID:
NCT06089460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069466', 'term': 'Red Meat'}], 'ancestors': [{'id': 'D008460', 'term': 'Meat'}, {'id': 'D005502', 'term': 'Food'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)', 'description': 'In kilograms'}], 'secondaryOutcomes': [{'measure': 'Fasting lipid panels (i.e., total cholesterol, HDL, LDL, VLDL, triglycerides)', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)', 'description': 'Total cholesterol (mg/dL), HDL (mg/dL), LDL (mg/dL), triglycerides (mg/dL)'}, {'measure': 'Fasting blood glucose', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)', 'description': 'In mg/dL'}, {'measure': 'Yale Food Addiction Scale', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)', 'description': 'Continuous score = 0-7 (higher = more symptoms of food addiction)'}, {'measure': 'Skin carotenoids', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)', 'description': 'Systolic and diastolic (mmHg)'}, {'measure': 'Dietary patterns (3-day diet records)', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)'}, {'measure': 'Behavioral Activation Scale Reward Responsiveness', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)', 'description': 'Score ranges 5-20, higher scores indicate greater reward responsiveness'}, {'measure': 'Ad-Libitum Ultra-Processed Food Consumption', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)', 'description': 'Reported in weight of food consumed, greater than or equal to 0 grams'}, {'measure': 'Sensitivity to Punishment and Reward Questionnaire (Reward Questions)', 'timeFrame': 'Baseline (week 0), T1 (week 4), T2 (week 8)', 'description': 'Score ranges 0-24, higher indicates greater sensitivity to reward'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this three-arm, pilot, randomized controlled trial is to examine the metabolic and behavioral impacts of consuming a diet characterized by protein from red meat, a meat analogue, or beans/legumes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-55 years of age\n* Willingness to consume any of the three protein sources\n* Willingness to stop consumption of any pre- or pro-biotic supplements\n* Willingness to follow a meal plan for four weeks\n\nExclusion Criteria:\n\n* Medical condition which precludes consumption of specific foods or whole food groups'}, 'identificationModule': {'nctId': 'NCT06089460', 'briefTitle': 'Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'Longitudinal Examination of Metabolic and Behavioral Correlates of Various Protein Food Sources', 'orgStudyIdInfo': {'id': 'IRB-22-297-STW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beef', 'description': 'Individuals will be asked to consume beef as their only source of protein and follow an individualized meal plan for 4 weeks. Thereafter, they will be instructed to continue beef consumption with any other foods desired for 4 weeks.', 'interventionNames': ['Other: Beef']}, {'type': 'EXPERIMENTAL', 'label': 'Meat analogue', 'description': 'Individuals will be asked to consume a commercial meat analogue product as their only source of protein and follow an individualized meal plan for 4 weeks. Thereafter, they will be instructed to continue the meat analogue consumption with any other foods desired for 4 weeks.', 'interventionNames': ['Other: Meat analogue']}, {'type': 'EXPERIMENTAL', 'label': 'Beans/legumes', 'description': 'Individuals will be asked to consume beans/legumes as their only source of protein and follow an individualized meal plan for 4 weeks. Thereafter, they will be instructed to continue the bean/legume consumption with any other foods desired for 4 weeks.', 'interventionNames': ['Other: Beans/legumes']}], 'interventions': [{'name': 'Beef', 'type': 'OTHER', 'description': 'Fresh, locally-sourced, grass-fed, grass-finished ground beef sufficient to meet protein needs based on body weight for 8 weeks', 'armGroupLabels': ['Beef']}, {'name': 'Meat analogue', 'type': 'OTHER', 'description': 'Commercially-available and purchased meat analogue sufficient to meet protein needs based on body weight for 8 weeks', 'armGroupLabels': ['Meat analogue']}, {'name': 'Beans/legumes', 'type': 'OTHER', 'description': 'Canned beans/legumes sufficient to meet protein needs based on body weight for 8 weeks', 'armGroupLabels': ['Beans/legumes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74078', 'city': 'Stillwater', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State University', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}