[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03233256":3,"trial-entities:NCT03233256":72,"trial-summary:NCT03233256":75},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":53,"locations":55,"central_contacts":65,"overall_officials":66,"references":70,"see_also_links":71},"NCT03233256","16-2203","Measurements of Water in Breath and Saliva","Rapid Measurements of Water Isotopes in Human Breath and Saliva for Doubly Labeled Water Analysis","ENROLLING_BY_INVITATION","2026-12","2025-12","2025-12-19","2018-02-27","University of Colorado, Denver","OTHER",false,"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.","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.",[19],"Human Energy Expenditure",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},60,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.","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.",[34],"Healthy adults (18-45 yrs.)",[36],{"measure":37,"description":38,"timeFrame":39},"Natural abundances of 2H:1H and 18O:16O in humans","Evaluation of the natural abundances of 2H:1H and 18O:16O in urine, saliva, and breath of humans.","Baseline",[],"ALL","18 Years","45 Years",true,{"inclusion":46,"exclusion":48,"raw_text":52},[47],"Healthy adult men and women, aged 18-45 yrs",[49,50,51],"Obesity (body mass index (BMI) \\> 30 kg\u002Fm2)","Pregnant or lactating women","Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)","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\u002Fm2)\n* Pregnant or lactating women\n* Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)",[54],"ADULT",[56],{"facility":57,"city":58,"state":59,"zip":60,"country":61,"geoPoint":62},"Edward Melanson","Aurora","Colorado","80045","United States",{"lat":63,"lon":64},39.72943,-104.83192,[],[67],{"name":68,"affiliation":13,"role":69},"Edward L Melanson, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":73,"biomarkers":74},[19],[],{"nct_id":4,"found":15,"summary":76,"prompt_version":76},null]