Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-06 @ 1:51 PM
Study NCT ID:
NCT02984358
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2016-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum uric acid concentrations', 'timeFrame': 'Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)'}], 'secondaryOutcomes': [{'measure': 'Glycaemia and serum insulin - insulin sensitivity (oral glucose tolerance test)', 'timeFrame': 'Measured at baseline and after 1 week intervention (day 8)'}, {'measure': 'IL-6', 'timeFrame': 'Measured at baseline and after 1 week intervention (day 8)'}, {'measure': '24 h blood glucose homeostasis - measured using a Dexcom CGMS', 'timeFrame': 'Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)'}, {'measure': 'Metabolomics (using Nuclear Magnetic Resonance - NMR)', 'timeFrame': 'Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '35623844', 'type': 'DERIVED', 'citation': 'Coelho MOC, Monteyne AJ, Kamalanathan ID, Najdanovic-Visak V, Finnigan TJA, Stephens FB, Wall BT. High dietary nucleotide consumption for one week increases circulating uric acid concentrations but does not compromise metabolic health: A randomised controlled trial. Clin Nutr ESPEN. 2022 Jun;49:40-52. doi: 10.1016/j.clnesp.2022.04.022. Epub 2022 Apr 25.'}]}, 'descriptionModule': {'briefSummary': "Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption, with or without a reduced nucleotide content, on markers of metabolic health, such as uric acid concentrations, blood glucose control and blood lipid profiles."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 18 and 30\n\nExclusion Criteria:\n\n* On medication (except contraception)\n* Smokers\n* Diagnosed with any metabolic or cardiovascular conditions\n* BMI \\< 18 or \\> 30\n* Dietary restrictions (vegetarians/vegans, etc.)'}, 'identificationModule': {'nctId': 'NCT02984358', 'acronym': 'MYTH', 'briefTitle': 'Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'Effect of Chronic Mycoprotein Consumption, and of Its Nucleotide Content, in Uric Acid Concentrations and Other Markers of Metabolic Health in Adults', 'orgStudyIdInfo': {'id': '660065613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Animal protein based diet', 'description': 'Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by animal products (meat and fish).', 'interventionNames': ['Other: Animal protein based diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-nucleotide mycoprotein based diet', 'description': 'Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-depleted mycoprotein products (commercial Quorn products).', 'interventionNames': ['Other: Low-nucleotide mycoprotein based diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-nucleotide mycoprotein based diet', 'description': 'Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-rich mycoprotein products.', 'interventionNames': ['Other: High-nucleotide mycoprotein based diet']}], 'interventions': [{'name': 'Animal protein based diet', 'type': 'OTHER', 'armGroupLabels': ['Animal protein based diet']}, {'name': 'Low-nucleotide mycoprotein based diet', 'type': 'OTHER', 'armGroupLabels': ['Low-nucleotide mycoprotein based diet']}, {'name': 'High-nucleotide mycoprotein based diet', 'type': 'OTHER', 'armGroupLabels': ['High-nucleotide mycoprotein based diet']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}