Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-05 @ 12:27 PM
Study NCT ID:
NCT03233256
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-19
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurements of Water in Breath and Saliva
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Healthy adults (18-45 yrs.) will be recruited from the local Denver area. The investigators have elected to study a relatively homogenous sample to limit the impact of age, weight, and chronic disease on isotope fractionation in breath.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Natural abundances of 2H:1H and 18O:16O in humans', 'timeFrame': 'Baseline', 'description': 'Evaluation of the natural abundances of 2H:1H and 18O:16O in urine, saliva, and breath of humans.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Energy Expenditure']}, 'descriptionModule': {'briefSummary': 'This study proposes to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva and breath by comparing the natural abundances of 2H:1H and 18O:16O in saliva and urine of un-dosed humans.', 'detailedDescription': 'The scientific premises for this line of research are 1) challenges related to costs, the complexity of sample collection and preparation, and the level of technical skills required for Isotope-ratio mass spectrometry (IRMS) analysis have limited the adoption of the doubly labeled water (DLW) method; and 2) the investigators preliminary data demonstrates that Off-Axis Integrated Cavity Output Spectroscopy (OA-ICOS) provides a valid, more rapid, and less technically challenging approach to isotopic analysis of human samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult men and women, aged 18-45 yrs\n\nExclusion Criteria:\n\n* Obesity (body mass index (BMI) \\> 30 kg/m2)\n* Pregnant or lactating women\n* Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)'}, 'identificationModule': {'nctId': 'NCT03233256', 'briefTitle': 'Measurements of Water in Breath and Saliva', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Rapid Measurements of Water Isotopes in Human Breath and Saliva for Doubly Labeled Water Analysis', 'orgStudyIdInfo': {'id': '16-2203'}, 'secondaryIdInfos': [{'id': 'R21DK113401', 'link': 'https://reporter.nih.gov/quickSearch/R21DK113401', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy adults (18-45 yrs.)', 'description': 'Healthy adults (18-45 yrs.) will be recruited from the local Denver area. The investigators have elected to study a relatively homogenous sample to limit the impact of age, weight, and chronic disease on isotope fractionation in breath.', 'interventionNames': ['Procedure: Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.']}], 'interventions': [{'name': 'Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.', 'type': 'PROCEDURE', 'description': 'The investigators propose to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva and breath. The natural abundances of 2H:1H and 18O:16O of urine, saliva, and breath samples will be determined from samples obtained simultaneously from 50 relatively healthy human subjects. We will also measure 2H:1H and 18O:16O enrichments in urine, saliva, and breath of 10 relatively healthy human subjects obtained after consuming a standard DLW dose and compare the estimates of TDEE using these different matrices.', 'armGroupLabels': ['Healthy adults (18-45 yrs.)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Edward Melanson', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Edward L Melanson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}