Measurements of Water in Breath and Saliva

University of Colorado Denver (CU Denver)

Status: Invitation-only

Conditions: Human Energy Expenditure

Treatments: Procedure: Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03233256

16-2203

R21DK113401 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Healthy adults (18-45 yrs.)

Experimental group

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.

Treatment:

Procedure: Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.