Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04486105
Status:
UNKNOWN
Last Update Posted:
2020-07-24
First Post:
2020-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Sucrose Intake, Markers of Health and Biomarker Identification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013395', 'term': 'Sucrose'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'change in blood pressure following one week intervention', 'description': 'Measurement of systolic and diastolic blood pressure'}, {'measure': 'Metabolome', 'timeFrame': 'change in the urinary metabolome following one week intervention', 'description': 'Metabolite profiling of urine samples, obtaining a profile of approximately 5000 metabolite intensities in urine'}, {'measure': 'Body composition', 'timeFrame': 'change in body mass index following one week intervention', 'description': 'measurement of body mass index'}, {'measure': 'Body composition', 'timeFrame': 'change in percentage body fat following one week intervention', 'description': 'measurement of percentage body fat'}], 'secondaryOutcomes': [{'measure': 'food diary analysis', 'timeFrame': 'change in dietary intake following the week intervention', 'description': 'measurement of energy, macro and micronutrient intakes from 3-day food diaries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Exposure', 'Metabolic Disturbance']}, 'descriptionModule': {'briefSummary': 'With free sugar intake proving to be of a concern within the general public, discovery and validation of a new biomarker will allow for more consistent measurement of sucrose intake. Furthermore, using a multi-omic approach the investigators will identify metabolic perturbations to the metabolome and proteome.', 'detailedDescription': 'Excessive free sugar intake is of concern within the general public, as intakes have been associated with weight gain and cardiovascular disease. Average intakes are over double that of the 5% of total energy intake that is recommended by the Science Advisory Committee on Nutrition, but intakes are calculated from observational measures that lack sensitivity and discovery and validation of a new biomarker from biological fluids may allow for more specific measurement and a better understanding of intake:disease relationships. Furthermore, understanding the biochemistry of sucrose intake will allow the identification of damage occurrence and alternative metabolic pathways, as well as novel protein damage that occur with chronic sucrose exposure.\n\nThis study aims to identify a biomarker of chronic sucrose consumption using metabolite profiling technology. The study will be composed of a randomised controlled intervention trial, in which participants will be required to consume an amount of sucrose (0-120g/d) every day for 7 days and provide biofluid samples (urine and blood) before the initiation, during and following the intervention; that will undergo metabolic analysis. Furthermore, participants will have their anthropometrics and dietary intake monitored throughout the study. The biomarker will also be validated against the dietary information and correlated with indices of health and sucrose-induced damage. The investigators will also monitor the feasibility and acceptability of chronic sucrose intake during the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 19-64, healthy diagnosis\n\nExclusion Criteria:\n\n* gastrointestinal issues, doesn't consume sugar"}, 'identificationModule': {'nctId': 'NCT04486105', 'briefTitle': 'Chronic Sucrose Intake, Markers of Health and Biomarker Identification', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'Investigation of Sucrose-induced Metabolic Adaptation and Biomarkers of Chronic Sucrose Intake in Humans Using a Multi-omic Approach', 'orgStudyIdInfo': {'id': '15738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'vehicle only for one week', 'interventionNames': ['Dietary Supplement: sucrose']}, {'type': 'EXPERIMENTAL', 'label': '40g sucrose ingestion', 'description': '40g sucrose treatment on top of habitual diet for one week', 'interventionNames': ['Dietary Supplement: sucrose']}, {'type': 'EXPERIMENTAL', 'label': '80g sucrose ingestion', 'description': '80g sucrose treatment on top of habitual diet for one week', 'interventionNames': ['Dietary Supplement: sucrose']}, {'type': 'EXPERIMENTAL', 'label': '120g sucrose ingestion', 'description': '120g sucrose treatment on top of habitual diet for one week', 'interventionNames': ['Dietary Supplement: sucrose']}], 'interventions': [{'name': 'sucrose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'pure sucrose in water in addition to habitual diet', 'armGroupLabels': ['120g sucrose ingestion', '40g sucrose ingestion', '80g sucrose ingestion', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 7ST', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Northumberland Building', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'John Lodge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'John Lodge', 'investigatorAffiliation': 'Northumbria University'}}}}