Measurements of Water in Breath and Saliva

NCT03233256 | Enrolling By Invitation

• 2 other identifiers: 16-2203R21DK113401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Energy Expenditure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy adults (18-45 yrs.)

EXPERIMENTAL

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.

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

Interventions

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.

Healthy adults (18-45 yrs.)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult men and women, aged 18-45 yrs

You may not qualify if:

• Obesity (body mass index (BMI) \> 30 kg/m2)
• Pregnant or lactating women
• Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Edward Melanson

Aurora, Colorado, 80045, United States

Location

Study Officials

• Edward L Melanson, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 28, 2017
• Study Start: February 27, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)