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Enrolling by Invitation

NCT Number: NCT03233256

Measurements of Water in Breath and Saliva

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.

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Key information

Conditions

Human Energy Expenditure

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Melanson

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. Natural abundances of 2H:1H and 18O:16O in humans

    Time frame: Baseline

    Evaluation of the natural abundances of 2H:1H and 18O:16O in urine, saliva, and breath of humans.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Rapid Measurements of Water Isotopes in Human Breath and Saliva for Doubly Labeled Water Analysis

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2017
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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