Measurements of Water in Breath and Saliva
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Feasibility of measuring 2H:1H and 18O:16O in saliva and breath..
- Who it may be relevant to
- Registry conditions: Human Energy Expenditure. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Rapid Measurements of Water Isotopes in Human Breath and Saliva for Doubly Labeled Water Analysis
Overview
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.
Detailed description
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.
Interventions
- 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
Primary outcome measures
- Natural abundances of 2H:1H and 18O:16O in humans [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Healthy adult men and women, aged 18-45 yrs
Exclusion criteria
- Obesity (body mass index (BMI) > 30 kg/m2)
- Pregnant or lactating women
- Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Edward Melanson — Aurora
Identifiers
NCT: NCT03233256 · 16-2203 · R21DK113401