Measurements of Water in Breath and Saliva

Not Applicable

• Conditions: Human Energy Expenditure

• Registration Number: NCT03233256
• Lead Sponsor: University of Colorado, Denver

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.

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.

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Study Start: 2018-02-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Edward Melanson; 🇺🇸 Aurora, Colorado, United States