Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT06507735
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Mannose Supplementation on Glycosylation and Protein Levels in Human Sera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008358', 'term': 'Mannose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes to glycan structure', 'timeFrame': '~1 month', 'description': 'Glycopeptide mass spectrometry will be applied to the major glycoproteins present in serum.'}, {'measure': 'Change in glycoprotein levels', 'timeFrame': '~1 month', 'description': 'Standard laboratory methods such as ELISA in either research or clinical laboratory settings (Roche Cobas or similar platform).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physiological Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of our study is to investigate the effects of supplemental mannose on sera of humans who are healthy. We will perform proteomics studies to elucidate changes to glycan structure and protein level changes. We hypothesize that we may find that mannose supplies more properly glycosylated protein substrate and helps expedite protein synthesis, that excess mannose leads to alternative glycan structures which confer improved stability, or that there are new sites that become glycosylated after mannose supplementation.', 'detailedDescription': 'Subjects will be enrolled and a baseline blood sample taken. Subjects will take mannose supplements for 1 week (3-4 packets of a standard dose in water), then a follow up blood sample will be taken.\n\nSubject blood will be analyzed by proteomic analysis for 1) change in glycan structure or 2) other protein based approaches to measure changes in levels of proteins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* No known medical conditions\n* Taking no medications or nutritional supplements\n* Agree to the study and provide informed consent\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Known medical diagnosis, including pregnancy\n* Presently taking medications and/or nutritional supplements\n* Do not provide consent'}, 'identificationModule': {'nctId': 'NCT06507735', 'briefTitle': 'The Effects of Mannose Supplementation on Glycosylation and Protein Levels in Human Sera', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'The Effects of Mannose Supplementation on Glycosylation and Protein Levels in Human Sera', 'orgStudyIdInfo': {'id': 'STU-2024-0127'}, 'secondaryIdInfos': [{'id': 'Velos Study Number', 'type': 'OTHER', 'domain': '58400'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mannose supplementation', 'description': 'Mannose supplementation will be given and subjects will be studied at baseline and after treatment.', 'interventionNames': ['Dietary Supplement: Mannose']}], 'interventions': [{'name': 'Mannose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mannose is a sugar monomer that is important in the glycosylation of many proteins. The concentration of mannose in mammalian plasma is \\~50-100 μM, which is primarily derived from N-glycan processing. Taking dietary mannose supplements can raise the levels of plasma mannose by 3- to 5-fold. There are currently no known adverse effects of mannose supplementation in humans.', 'armGroupLabels': ['Mannose supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Jeffrey SoRelle, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jeffrey SoRelle', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}