Measurements of Water in Breath and Saliva

Human Energy Expenditure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03233256
• Other study ID #: 16-2203
• Secondary ID: R21DK113401
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 27, 2018
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Human Energy Expenditure

Intervention

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 different matrices.

Locations

Country	Name	City	State
United States	Edward Melanson	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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