Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-30 @ 9:44 AM
Study NCT ID:
NCT06624033
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2020-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Legume Proteins in Differents Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single-centre randomized, cross-over controlled trial.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'participants may receive 6 products in 6 interventions sequentially during the protocol'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '0 minute before the consumption of the test meals', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal)'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '15 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '30 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '60 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '90 minutes after ingestion meals', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '120 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '150 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '180 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '210 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '240 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '270 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '300 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).One point at 300 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of leucinemia', 'timeFrame': '360 minutes after ingestion', 'description': 'Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.'}], 'secondaryOutcomes': [{'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '0 minute before the consumption of the test meals,', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '15 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '30 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '45 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 45 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '60 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '90 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '120 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '180 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '210 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '240 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '270 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '300 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 300 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes in the plasma concentrations of the others amino acids', 'timeFrame': '360 minutes after ingestion', 'description': 'Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '0 minute before the consumption of the test meals', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '15 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '30 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '45 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 45 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '60 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '90 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '120 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '150 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '180 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '210 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '240 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '270 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '300 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 300 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of Blood sugar levels', 'timeFrame': '360 minutes after ingestion', 'description': 'Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '0 minute before the consumption of the test meals', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '15 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '30 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '45 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 45 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '60 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '90 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '120 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '150 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '180 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '210 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '240 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '270 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '300 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 300 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of insulin levels', 'timeFrame': '360 minutes after ingestion', 'description': 'Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '0 minute before the consumption of the test meals', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '15 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '30 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '45 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 45 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '60 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '90 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '120 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '150 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '180 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '210 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '240 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '270 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '300 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 300 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes lipid profile', 'timeFrame': '360 minutes after ingestion', 'description': 'Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)', 'timeFrame': '0 minute before the consumption of the test meals', 'description': 'Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.'}, {'measure': 'Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)', 'timeFrame': '15 minutes after ingestion', 'description': 'Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)', 'timeFrame': '30 minutes after ingestion', 'description': 'Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)', 'timeFrame': '60 minutes after ingestion', 'description': 'Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)', 'timeFrame': '90 minutes after ingestion', 'description': 'Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)', 'timeFrame': '120 minutes after ingestion', 'description': 'Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)', 'timeFrame': '150 minutes after ingestion', 'description': 'Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)', 'timeFrame': '240 minutes after ingestion', 'description': 'Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.'}, {'measure': 'Areas under curves', 'timeFrame': '0 minute before the consumption of the test meals', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '15 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '30 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '60 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '90 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '120 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '180 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '240 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '300 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}, {'measure': 'Areas under curves', 'timeFrame': '360 minutes after ingestion', 'description': 'maximum concentration and time to reach this concentration will be compared between test meals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amino acid', 'legume', 'pea', 'protein'], 'conditions': ['Healthy', 'Men']}, 'descriptionModule': {'briefSummary': 'The use of pea proteins could be interesting in specific foods. Indeed, these proteins could have great nutritional quality, with good amino acid profile. Therefore, the investigators study the bioavailability of protein and post-prandial variation of metabolic markers following consumption of pea protein-enriched products in healthy young subjects.\n\nMain Objective is to compare plasma kinetics of leucine.', 'detailedDescription': 'The written agreement of the subjects will be obtained after information on the aims, nature and possible risks of the study.\n\nBefore inclusion, the volunteers will be subjected to a medical check-up at the Nutritional Exploration Unit which includes an examination of personal and family history and current drug treatments, as well as a standard medical examination and a blood test for a biological check-up. Compliance with the inclusion/ exclusion criteria will be verified during this review.\n\nVolunteers included in the protocol will go to the Clinical Pharmacology Center (CPC) to perform the tests. At each visit, each volunteer will receive one of the six products.\n\nThe volunteer will be reviewed six times for the realization of a kinetics. First, three visits will be made with at least 7 days apart (wash out period). Then, after a 15-day break, three others visits will be organized spaced at least 7 days apart. The day before each visit, the evening meal will be standardized and eaten before 9 pm. A short catheter will be placed in a vein in the forearm for blood samples. After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion.\n\nOn these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. Any intercurrent events will be noted in the observation book. The test meal sequence will be randomly assigned to subjects (generating a random list) prior to the start of the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major male volunteers under 30 (\\<30)\n* Body mass index between 22 and 28 kg/m²\n* Subjects considered healthy by investigator based on the examination, medical and clinical examination,\n* biological check up considered compatible with study participation\n* person who is in the position to sign informed consent\n\nExclusion Criteria:\n\n* Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),\n* Subject weight \\< 60 kg\n* Subject refusing to consume one of the proposed products or the test meal\n* Subject with a food allergy(s) to one or more components of the study products (gluten, legumes, etc.), or with a contribution to the consumption of these products.\n* Subject with tumor pathology, inflammatory, moderate to severe kidney failure, malabsorption syndrome,\n* Subject being under drug treatment or dietary supplement that may influence the results of kinetics: treatments that may affect gastric emptying, intestinal absorption (smectite-based intestinal dressings, etc.), insulin and blood sugar, Oral nutritional supplements (NOC), proton pump inhibitors (PPIs), corticosteroids, nonsteroidal anti-inflammatory drugs, antibiotics for less than a month,\n* Subject with diabetes or dyslipidemia,\n* Subject with a heavy medical or surgical history that may pose a risk to the volunteer under the protocol,\n* Subject who has undergone surgery that may interfere with the objectives of the study (at the discretion of the investigating physician) within 3 months preceding the study,\n* Person refusing to be registered on the National File of Healthy Volunteers of the Ministry of Health,\n* Major subject under trusteeship or with limited rights,\n* Subject not affiliated with social security,\n* Subject during the exclusion period of a previous study (after verification in the Biomedical Research Volunteers File).'}, 'identificationModule': {'nctId': 'NCT06624033', 'acronym': "LEG'UP", 'briefTitle': 'Bioavailability of Legume Proteins in Differents Products', 'organization': {'class': 'OTHER', 'fullName': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}, 'officialTitle': 'Single-blind, Randomized, Cross-over Comparative Bioavailability Study About the Kinetics of Plasma Amino Acid Concentrations Subsequent to the Consumption of Innovative Legume-based Products.', 'orgStudyIdInfo': {'id': 'CRNH 1 -2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chocolate cake with peas', 'description': 'the subjects will consume the test meals (arm title)', 'interventionNames': ['Other: amino acids kinetics']}, {'type': 'EXPERIMENTAL', 'label': 'Biscuit with peas', 'description': 'the subjects will consume the test meals (arm title).', 'interventionNames': ['Other: amino acids kinetics']}, {'type': 'EXPERIMENTAL', 'label': 'chopped steack with peas', 'description': 'the subjects will consume the test meals (arm title).', 'interventionNames': ['Other: amino acids kinetics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Chocolate cake with gluten', 'description': 'the subjects will consume the test meals (arm title)', 'interventionNames': ['Other: amino acids kinetics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'biscuit with gluten', 'description': 'the subjects will consume the test meals (arm title).', 'interventionNames': ['Other: amino acids kinetics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'chopped steack', 'description': 'the subjects will consume the test meals (arm title).', 'interventionNames': ['Other: amino acids kinetics']}], 'interventions': [{'name': 'amino acids kinetics', 'type': 'OTHER', 'description': 'After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion.\n\nOn these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured.', 'armGroupLabels': ['Biscuit with peas', 'Chocolate cake with gluten', 'Chocolate cake with peas', 'biscuit with gluten', 'chopped steack', 'chopped steack with peas']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63009', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'facility': "Centre de Recherche en Nutrition Clinique d'Auvergne", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Marine Gueugneau, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}, 'collaborators': [{'name': "Centre de Recherche en Nutrition Humaine d'Auvergne", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Associate', 'investigatorFullName': 'Adeline BLOT', 'investigatorAffiliation': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}}}}