Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-22 @ 10:11 AM
Study NCT ID:
NCT02231502
Status:
UNKNOWN
Last Update Posted:
2014-11-11
First Post:
2014-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovation in Food Production Techniques to Improve Bioactive Content
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-10', 'studyFirstSubmitDate': '2014-08-27', 'studyFirstSubmitQcDate': '2014-09-01', 'lastUpdatePostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24hr excretion of bioactive compounds', 'timeFrame': '24h', 'description': 'A range of bioactive compounds found in vegetables, and their metabolites, will be assessed in blood and/or urine samples collected over a 24 hour period.'}]}, 'conditionsModule': {'keywords': ['Bioavailability in healthy individuals'], 'conditions': ['Bioavailability']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish to what extent innovations in food production techniques may facilitate retention of bioactive compounds in healthy individuals.\n\nThe study has a single-blinded (outcome assessor), cross-over design; wherein, the plasma concentration and urinary excretion levels of a range of bioactive compounds will be assessed over a 24 hour period following intake of either a vegetable based convenience food, or a minimally processed meal containing the same vegetable materials.\n\nTo do this, 20 healthy volunteers will attend two assessment days (and a follow-up assessment at +24hr) and will provide blood and urine samples, which will be collected at biologically relevant times over the 24 hour period. In this cross-over study, each meal will be eaten on separate days, with a wash-out period of at least 1 week between assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women\n* ≥ 18 years old\n* Successful biochemical, haematological and urinalysis assessment at screening\n\nExclusion Criteria:\n\n* Current smokers, or ex-smokers ceasing \\< 3 months ago\n* Pregnant women, or those currently breast feeding\n* Subjects with existing or significant past medical history of medical conditions likely to affect the study measures i.e. diabetes, hepatic, renal, digestive or cancer (excluding Basal-cell carcinoma) - to be judged by the study clinical advisor.\n* Those unprepared to adhere to dietary restrictions for 3d preceding and during each assessment day.\n* Parallel participation in another research project involving dietary intervention and/or sampling of biological fluids/material.\n* Those on therapeutic diets or having experienced substantial weight loss (to be judged by clinical advisor) within 3 month of screening\n* Taking dietary supplements containing flavonoids, isothiocyanates or carotenes (including multivitamins) (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements.\n* Prescribed medications likely to affect ADME (absorption, distribution, metabolism, and excretion); medications to be assessed for suitability by the clinical advisor.\n* Clinical advisor judged: abnormal biochemical, haematological or urinary results or measurements considered to be counter indicative for the study: including kidney and liver function, fasting glucose (especially if indicative of diabetes), lipid abnormalities, full blood count.'}, 'identificationModule': {'nctId': 'NCT02231502', 'acronym': 'ENRICH', 'briefTitle': 'Innovation in Food Production Techniques to Improve Bioactive Content', 'organization': {'class': 'OTHER', 'fullName': 'University of East Anglia'}, 'officialTitle': 'Optimising Vegetable Based Convenience Food Production to Retain Compounds Found in Vegetables', 'orgStudyIdInfo': {'id': '14/EE/0070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vegetable-based convenience food', 'description': 'One time ingestion of a vegetable-based convenience product. Dietary restrictions will be observed (i.e. avoidance of some vegetables) for 3 days prior to the bioavailability assessment (a list of foods to avoid will be provided).\n\nAt least 7 days wash-out between each assessment visit.', 'interventionNames': ['Other: Vegetable-based convenience food']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vegetable meal', 'description': 'One time ingestion of a minimally processed vegetable meal. Dietary restrictions will be observed (i.e. avoidance of some vegetables) for 3 days prior to the bioavailability assessment (a list of foods to avoid will be provided).\n\nAt least 7 days wash-out between each assessment visit.', 'interventionNames': ['Other: Vegetable meal']}], 'interventions': [{'name': 'Vegetable-based convenience food', 'type': 'OTHER', 'armGroupLabels': ['Vegetable-based convenience food']}, {'name': 'Vegetable meal', 'type': 'OTHER', 'armGroupLabels': ['Vegetable meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NR4 7TJ', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Norwich Medical School', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}], 'overallOfficials': [{'name': 'Aedin Cassidy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of East Anglia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of East Anglia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quadram Institute Bioscience', 'class': 'OTHER'}, {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}