Measurements of Water in Breath and Saliva

Sponsor

University of Colorado, Denver (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03233256

Collaborator

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

Enrollment

Location

Arm

69.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Energy Expenditure	Procedure: Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 27, 2018

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

Arm

Intervention/Treatment

Experimental: Healthy adults (18-45 yrs.)

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edward Melanson	Aurora	Colorado	United States	80045

Sponsors and Collaborators

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

Investigators

Principal Investigator: Edward L Melanson, PhD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT03233256

Other Study ID Numbers:

16-2203
R21DK113401

First Posted:

Jul 28, 2017

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 18, 2022