Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-21 @ 9:46 AM
Study NCT ID:
NCT02217605
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2014-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
31P Magnetic Resonance Spectroscopy Fructose Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005632', 'term': 'Fructose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-14', 'studyFirstSubmitDate': '2014-08-12', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic ATP reserves following an oral fructose challenge', 'timeFrame': '2 hours post prandial', 'description': 'Monitor hepatic ATP levels following an oral fructose challenge using 31P magnetic resonance spectroscopy'}], 'secondaryOutcomes': [{'measure': 'Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen', 'timeFrame': '2 hours post prandial', 'description': 'Measure baseline liver lipid and glycogen using magnetic resonance spectroscopy and correlate BMI, lipid and glycogen levels with rate of ATP depletion and recovery following an oral fructose challenge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NAFLD', 'Oral Fructose Challenge', '31P MRS', 'Liver', 'Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of an oral fructose challenge on liver adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a potential measure measure of liver health.', 'detailedDescription': 'This study uses 31P spectra acquired from the liver in healthy subjects following a fructose drink to monitor ATP levels. This is also related to baseline BMI, liver glycogen and liver lipid levels'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age 18 - 30\n* BMI 20 - 27 kg/m\\^2\n* Healthy\n\nExclusion Criteria:\n\n* Smokers\n* Liver disease or Metabolic Disorders\n* Metal implants (not suitable for MRI)'}, 'identificationModule': {'nctId': 'NCT02217605', 'acronym': '31PMRS_FRU', 'briefTitle': '31P Magnetic Resonance Spectroscopy Fructose Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Investigating the Effects of an Oral Fructose Challenge on Hepatic ATP Reserves in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A32006_FRU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fructose', 'description': 'Oral Fructose Challenge (75 g fructose in 500 ml water) followed by 75 minutes 31P MRS', 'interventionNames': ['Dietary Supplement: Fructose']}], 'interventions': [{'name': 'Fructose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast', 'armGroupLabels': ['Fructose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2RD', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'University of Nottingham', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Luca Marciani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stephen Bawden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biotechnology and Biological Sciences Research Council', 'class': 'OTHER'}, {'name': 'Unilever R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'CASE studentship researcher', 'investigatorFullName': 'Stephen Bawden', 'investigatorAffiliation': 'University of Nottingham'}}}}