Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-04 @ 4:53 PM
Study NCT ID:
NCT02497768
Status:
UNKNOWN
Last Update Posted:
2016-03-09
First Post:
2015-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Particle size distribution of masticated nuts', 'timeFrame': 'At time of expectoration, up to 90 seconds after each sample ingested', 'description': 'Particle size distribution of masticated nuts as measured by laser diffraction and sieving.'}], 'secondaryOutcomes': [{'measure': 'Lipid content of masticated nuts', 'timeFrame': 'At time of expectoration, up to 90 seconds after each sample ingested.', 'description': 'Lipid content of masticated nuts as measured by Soxhlet to be compared to predictions form mathematical model.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mastication', 'pistachios', 'brazils', 'participants'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25527747', 'type': 'BACKGROUND', 'citation': 'Grundy MM, Grassby T, Mandalari G, Waldron KW, Butterworth PJ, Berry SE, Ellis PR. Effect of mastication on lipid bioaccessibility of almonds in a randomized human study and its implications for digestion kinetics, metabolizable energy, and postprandial lipemia. Am J Clin Nutr. 2015 Jan;101(1):25-33. doi: 10.3945/ajcn.114.088328. Epub 2014 Nov 12.'}, {'pmid': '25310222', 'type': 'BACKGROUND', 'citation': 'Grassby T, Picout DR, Mandalari G, Faulks RM, Kendall CW, Rich GT, Wickham MS, Lapsley K, Ellis PR. Modelling of nutrient bioaccessibility in almond seeds based on the fracture properties of their cell walls. Food Funct. 2014 Dec;5(12):3096-106. doi: 10.1039/c4fo00659c.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to understand how oral processing (chewing) of nuts affects particle size and the presence of lipid (fat) on the cut surfaces.\n\nThe main objective of the study is to:\n\nMeasure the size of nut particles that have been chewed sufficiently to be swallowed.\n\nThe secondary objective of this study is to:\n\nMeasure any changes in lipid content due to chewing and compare it to a prediction from a theoretical model.\n\nThe investigators have developed a theoretical model for determining the release of nutrients from plant foods, specifically lipid (fat) from almonds. The model has been used to calculate the amount of lipid released from chewed almonds. The model shows that only about 10% of the lipid is immediately released. The investigators require information on the particle size distribution (number of particles of each size) for other chewed nuts to calculate the amount of lipid released for other nuts. This will allow us to check the validity of our model for other foods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be generally healthy\n* Must have eaten nuts within the last month with no adverse effects\n\nExclusion Criteria:\n\n* Must not be allergic to nuts of any kind\n* Must not have any teeth missing (apart from unerupted wisdom teeth)\n* Must not have bleeding gums\n* Must not have had dental treatment (other than checkups) in the last 3 months\n* Must not be currently suffering from any infectious disease that may be passed on via saliva e.g. Glandular fever, flu'}, 'identificationModule': {'nctId': 'NCT02497768', 'briefTitle': 'Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils', 'orgStudyIdInfo': {'id': '15/WS/0104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chewing of nuts', 'description': '8 samples (4-5 g) of nuts (pistachios or Brazils) on two separate visit days.', 'interventionNames': ['Other: Chewing of nuts']}], 'interventions': [{'name': 'Chewing of nuts', 'type': 'OTHER', 'description': 'The volunteers will be asked to chew and spit 8 portions (4-5 g) of nuts (pistachios or Brazils) on two separate visits. They will provide samples for particle sizing. Two portions will be used as practice samples in order to measure the number of chews. Two portions will be sieved. Two portions will be measured by laser diffraction. Two portions will be frozen for later lipid analysis.', 'armGroupLabels': ['Chewing of nuts']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Diabetes and Nutritional Sciences Division, School of Medicine, King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Sarah EE Berry, BSc MSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}