Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT06381869
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Pea Protein in Young and Old Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078724', 'term': 'Pea Proteins'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leucine blood concentration', 'timeFrame': '0 minute before eating the test meals, then regularly until 360 minutes after ingestion.'}], 'secondaryOutcomes': [{'measure': 'Essential amino acids blood concentration (µmol/L)', 'timeFrame': '0 minute before eating the test meals, then regularly until 360 minutes after ingestion.'}, {'measure': 'Non essential amino acid blood concentration (µmol/L)', 'timeFrame': '0 minute before eating the test meals, then regularly until 360 minutes after ingestion.'}, {'measure': 'Blood glucose concentration (g/L)', 'timeFrame': '0 minute before eating the test meals, then regularly until 360 minutes after ingestion.'}, {'measure': 'Blood insulin concentration (μIU/ml)', 'timeFrame': '0 minute before eating the test meals, then regularly until 360 minutes after ingestion.'}, {'measure': 'Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l)', 'timeFrame': '0 minute before eating the test meals, then regularly until 360 minutes after ingestion.'}, {'measure': 'Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml)', 'timeFrame': '0 minute before eating the test meals, then regularly until 360 minutes after ingestion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protein', 'Bioavailability', 'Pea protein', 'Amino acidemia'], 'conditions': ['Healthy Male Volunteers']}, 'descriptionModule': {'briefSummary': 'The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male volunteers, aged over 65 or under 30\n* Body mass index (weight in kg/ height² in m²) between 22 and 28 kg/m²,\n* Subjects considered to be healthy by the principal investigator doctor according to the interview, medical and clinical examination,\n* Biological assessment considered compatible with participation in the study,\n* Persons able to sign the informed consent,\n* Persons affiliated to social security scheme.\n\nExclusion Criteria:\n\n* Pathologies or treatments not compatible with the study\n* Food allergy or a contraindication to the consumption of the products tested\n* Subject in a situation which, in the opinion of the investigator, could interfere with their optimal participation in the study or constitute a particular risk for the subject,\n* Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),\n* Subject weighing \\< 55 kg,'}, 'identificationModule': {'nctId': 'NCT06381869', 'acronym': 'NUTRALYS', 'briefTitle': 'Bioavailability of Pea Protein in Young and Old Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Roquette Freres'}, 'officialTitle': 'Study of Comparative Bioavailability, Randomized, in Open Cross Over the Kinetics of Subsequent Plasma Amino Acid Concentrations the Consumption of Pea Protein "NUTRALYS ® S85 Plus".', 'orgStudyIdInfo': {'id': 'CRNHA 2018-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Young volunteers', 'description': 'Volunteers under 30 years old', 'interventionNames': ['Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) in water', 'Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) within meal', 'Dietary Supplement: Whey protein in water', 'Dietary Supplement: Whey protein within meal']}, {'type': 'OTHER', 'label': 'Elderly volunteers', 'description': 'Volunteers over 65 years old.', 'interventionNames': ['Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) in water', 'Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) within meal', 'Dietary Supplement: Whey protein in water', 'Dietary Supplement: Whey protein within meal']}], 'interventions': [{'name': 'Pea protein (NUTRALYS ® S85 plus) in water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) in water containing 0,41 g of tested protein/kg of body weight.', 'armGroupLabels': ['Elderly volunteers', 'Young volunteers']}, {'name': 'Pea protein (NUTRALYS ® S85 plus) within meal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) within a meal containing 0,41 g of tested protein/kg of body weight.', 'armGroupLabels': ['Elderly volunteers', 'Young volunteers']}, {'name': 'Whey protein in water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'After selection and randomization, the subjects will consume per os whey protein in water containing 0,41 g of tested protein/kg of body weight.', 'armGroupLabels': ['Elderly volunteers', 'Young volunteers']}, {'name': 'Whey protein within meal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'After selection and randomization, the subjects will consume per os whey protein within a meal containing 0,41 g of tested protein/kg of body weight.', 'armGroupLabels': ['Elderly volunteers', 'Young volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63009', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': "Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roquette Freres', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Centre de Recherche en Nutrition Humaine d'Auvergne", 'class': 'OTHER_GOV'}, {'name': "Université d'Auvergne", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Nutrition Exploration Unit, Clinical professor', 'investigatorFullName': 'Ruddy Richard', 'investigatorAffiliation': "Université d'Auvergne"}}}}