Measurements of Water in Breath and Saliva

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Human Energy Expenditure
• Intervention / Treatment: Procedure: Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Edward Melanson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy adults (18-45 yrs.); 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Edward L Melanson, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 16-2203; R21DK113401 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No