Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT05584358
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2022-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protein Extrusion and Postprandial Amino Acid Handling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma amino acid concentrations', 'timeFrame': '5 hours', 'description': 'The rate of appearance of amino acids ingested in the drink'}], 'secondaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': '5 hours', 'description': 'The concentrations of glucose in the blood'}, {'measure': 'Serum insulin', 'timeFrame': '5 hours', 'description': 'The concentration of insulin in the blood'}, {'measure': 'Resting metabolic rate', 'timeFrame': '5 hours', 'description': 'The amount of energy used to digest the protein'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postprandial Plasma Amino Acid Availability']}, 'referencesModule': {'references': [{'pmid': '38797481', 'type': 'DERIVED', 'citation': 'West S, Monteyne AJ, Whelehan G, Abdelrahman DR, Murton AJ, Finnigan TJ, Mandalari G, Booth C, Wilde PJ, Stephens FB, Wall BT. High-Moisture Extrusion of a Dietary Protein Blend Impairs In Vitro Digestion and Delays In Vivo Postprandial Plasma Amino Acid Availability in Humans. J Nutr. 2024 Jul;154(7):2053-2064. doi: 10.1016/j.tjnut.2024.05.018. Epub 2024 May 24.'}]}, 'descriptionModule': {'briefSummary': "The bulk of research that has investigated the effect of dietary protein on muscle tissue in humans has used isolated, minimally processed protein powders. However, the protein that we consume on a daily basis has typically undergone various processing methods, and evidence suggests these can change the way our bodies metabolise the protein. 'Extrusion' is a common processing method that uses high pressure to produce protein containing cereals and meat replacement foods. There is currently no research looking at how extrusion affects the way a protein source is digested and absorbed in humans. This study will compare the availability of ingested protein in the blood in the hours following consumption of an extruded versus a non-extruded source."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 18 and 30.\n* Metabolically healthy\n\nExclusion Criteria:\n\n* Any metabolic impairments\n* cardio/pulmonary diseases.\n* Chronic use of the over the counter medicine\n* A personal or family history of epilepsy, seizures or schizophrenia.\n* Allergic to mycoprotein/Quorn/edible fungi/environmental mould products.'}, 'identificationModule': {'nctId': 'NCT05584358', 'acronym': 'BABE', 'briefTitle': 'Protein Extrusion and Postprandial Amino Acid Handling', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'The Impact of the Extrusion Process During Dietary Protein Production on in Vivo Postprandial Amino Acid Availability', 'orgStudyIdInfo': {'id': '21-10-20-A-06 v2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry Blend', 'description': 'A dry blend of mycoprotein and pea protein.', 'interventionNames': ['Dietary Supplement: Dry protein blend ingestion']}, {'type': 'EXPERIMENTAL', 'label': 'Extrudate', 'description': 'An extruded blend of mycoprotein and pea protein', 'interventionNames': ['Dietary Supplement: Extruded protein blend ingestion']}], 'interventions': [{'name': 'Dry protein blend ingestion', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of protein blend powders mixed in water', 'armGroupLabels': ['Dry Blend']}, {'name': 'Extruded protein blend ingestion', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of protein blend powders mixed in water', 'armGroupLabels': ['Extrudate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX1 2LU', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Sport & Health Sciences University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'EX1 2LU', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Benjamin Wall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Nutritional Physiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quorn', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}