Human Energy ExpenditureNCT03233256
Measurements of Water in Breath and Saliva
A study testing Feasibility of measuring 2H:1H and 18O:16O in saliva and breath. in people with Human Energy Expenditure, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Energy Expenditure
- What is being tested?
- Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women, aged 18-45 yrs
Who cannot join
- Obesity (body mass index (BMI) > 30 kg/m2)
- Pregnant or lactating women
- Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Energy Expenditure
- Being tested
- Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Feasibility of measuring 2H:1H and 18O:16O in saliva and breath. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start27 Feb 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Energy ExpenditureStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward L Melanson, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233256
- Sponsor's protocol ID
- 16-2203
- Other IDs
- R21DK113401
- Status last verified
- Dec 2025
- First submitted
- 25 Jul 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No