Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-10 @ 2:58 PM
Study NCT ID:
NCT05577858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-17
First Post:
2022-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein-Distinct Macronutrient-Equivalent Diet 1
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': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding will be implemented to the extent possible. A researcher, unaware of the study goals and not involved with downstream data analyses will use a 1:1 block randomization to allocate participants to the diets in the first arm. Food service personnel (care provider) will not be aware of study goals and allocations. Metabolomic assays will be run in a blinded manner.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ferritin', 'timeFrame': '16 weeks', 'description': 'Microplate assay'}, {'measure': 'Concentration of TMAO in blood', 'timeFrame': '16 weeks', 'description': 'Using LC/MS based method method'}, {'measure': 'Fasting blood glucose concentration in blood', 'timeFrame': '16 weeks', 'description': 'Using Glucometer'}], 'secondaryOutcomes': [{'measure': 'Body weight in kilograms', 'timeFrame': '16 weeks', 'description': 'Measurement'}, {'measure': 'Concentration of CRP in blood', 'timeFrame': '16 weeks', 'description': 'Microplate assay'}, {'measure': 'Gut microbiota composition and diversity', 'timeFrame': '16 weeks', 'description': '16S rRNA gene sequencing'}, {'measure': 'Fat and lean mass in kg using DXA for body composition measures', 'timeFrame': '16 weeks', 'description': 'DEXA scan'}, {'measure': 'Concentration of sulfur containing amino acids in blood', 'timeFrame': '16 weeks', 'description': 'LC/MS based method'}, {'measure': 'Digestible indispensable amino acid score using different amino acid concentrations', 'timeFrame': '16 weeks', 'description': 'Using standard equation'}, {'measure': 'Concentration of IGF-1 in blood', 'timeFrame': '16 weeks', 'description': 'Using Microplate assay kit'}, {'measure': 'Concentration of IGF-BP3 in blood', 'timeFrame': '16 weeks', 'description': 'Using Microplate assay kit'}, {'measure': 'Concentration of Fasting insulin in blood', 'timeFrame': '16 weeks', 'description': 'Using Microplate assay kit'}, {'measure': 'Peak heights of several complex lipids panel using metabolomics technique', 'timeFrame': '16 weeks', 'description': 'LC/MS based assay'}, {'measure': 'Concentration Short-chain fatty acid panel in stool', 'timeFrame': '16 weeks', 'description': 'using LC/MS based assay'}, {'measure': 'Peak heights of several Biogenic amines panel using metabolomics technique', 'timeFrame': '16 weeks', 'description': 'using LC/MS based assay'}, {'measure': 'Muscle strength using Isokinetic muscle testing', 'timeFrame': '16 weeks', 'description': 'Biodex ergometer'}, {'measure': 'Balance assessment using balance', 'timeFrame': '16 weeks', 'description': 'Mechanography'}, {'measure': 'Grip force per kg mass', 'timeFrame': '16 weeks', 'description': 'using Dynamometer'}, {'measure': 'Blood pressure in mm Hg', 'timeFrame': '16 weeks', 'description': 'Upper arm cuff'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Lifestyle']}, 'referencesModule': {'references': [{'pmid': '40291832', 'type': 'DERIVED', 'citation': 'de Vargas BO, Vaezi S, Freeling JL, Zhang Y, Weidauer L, Lee CL, Zhao J, Dey M. Design and Implementation of the Protein-Distinct Macronutrient-Equivalent Diet (PRODMED) Study: An Eighteen-Week Randomized Crossover Feeding Trial Among Free-Living Rural Older Adults. Curr Dev Nutr. 2025 Mar 24;9(5):104588. doi: 10.1016/j.cdnut.2025.104588. eCollection 2025 May.'}]}, 'descriptionModule': {'briefSummary': 'Plant-based diets are naturally low in Methionine (Met), and also low in precursor molecules (e.g L-carnitine, choline, betaine, etc.) producing microbiota-mediated proatherogenic TMAO. Among plant proteins, pulses are rich in micronutrients, and dietary fibers, making them ideal for microbiome-stimulating, nutrient-dense, healthful dietary patterns. However, daily pulse intake remains low at 8% in America despite recommendations by DGA, a resource to guide health promotion across communities. A significant body of preclinical data, waiting to be translated to humans, suggests that dietary Met restriction can trigger beneficial metabolic and anti-inflammatory adaptations leading to improved chronic health and longevity. The central hypothesis is that a pulse-protein-based healthy diet can be simultaneously equivalent to omnivorous diets in protein content and yet naturally lower in Met and TMAO to improve glycemic control, body composition, and immunometabolic flexibility to reduce the risk of chronic diseases and improve healthspan. The goal is to systematically elucidate for the first time the effects of a lacto-vegetarian feeding pattern with pulses as the primary protein source on a comprehensive panel of \\~500 traditional and next-generation biomarkers of health, and assess the role of the gut microbiota in mediating such effects. We also aim to interrogate the potential concern about the lower bioavailability of non-heme iron from pulses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally good health status based on routine physical in the past 12 months, current healthy status\n* Normal HbA1C, not underweight\n* Age 60 years or more, all races, both sexes and all education level\n* Do not have any special dietary requirements and willing to consume vegetarian diet\n* Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.\n\nExclusion Criteria:\n\n* Probiotic, long-term antibiotic, and tobacco/drug/alcohol use\n* Not on any special diet within 3 months of recruitment\n* Impaired kidney functions\n* Active history of cancer, diabetes, heart, liver, and kidney diseases\n* Major gastrointestinal disorders in the past 3 months\n* History of heart attacks or stroke\n* Unable to meet in-person visit requirements for dining, picking up meals, and tests\n* Any mental health condition that would affect the ability to provide written informed consent.\n* If they had not had a routine health checkup during the 12 months prior to recruitment.\n* If they were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.'}, 'identificationModule': {'nctId': 'NCT05577858', 'acronym': 'PRODMED1', 'briefTitle': 'Protein-Distinct Macronutrient-Equivalent Diet 1', 'organization': {'class': 'OTHER', 'fullName': 'South Dakota State University'}, 'officialTitle': 'Effect of a Pulse-based USDA-diet on Gut Microbial Metabolites and Biomarkers of Healthspan: A 18-week Randomized Controlled Crossover Feeding Study in Older Adults', 'orgStudyIdInfo': {'id': 'IRB-2209011-EXP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Meat based', 'description': 'Animal protein-based dietary intervention', 'interventionNames': ['Other: Meat based']}, {'type': 'EXPERIMENTAL', 'label': 'Pulse based', 'description': 'Pulse-protein-based dietary intervention', 'interventionNames': ['Other: Pulse based']}], 'interventions': [{'name': 'Meat based', 'type': 'OTHER', 'description': 'Omnivorous diet following dietary guidelines', 'armGroupLabels': ['Meat based']}, {'name': 'Pulse based', 'type': 'OTHER', 'description': 'Lacto-ovo-vegetarian pulse-based diet following dietary guidelines', 'armGroupLabels': ['Pulse based']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57007', 'city': 'Brookings', 'state': 'South Dakota', 'country': 'United States', 'facility': 'South Dakota State University, Wagner Hall 416', 'geoPoint': {'lat': 44.31136, 'lon': -96.79839}}], 'overallOfficials': [{'name': 'Moul Dey, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Dakota State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Dakota State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Moul Dey', 'investigatorAffiliation': 'South Dakota State University'}}}}