Measurement of Water in Breath and Saliva for Human Energy Expenditure

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Obesity, Pregnancy, Diabetes, Heart diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy adults without chronic diseases, it might be best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment for measuring 2H:1H and 18O:16O in saliva and breath?

The research shows that measuring deuterium and oxygen-18 in saliva is accurate and non-invasive, making it a good alternative to blood or urine sampling for assessing energy use in the body. This method has been validated in children and adults, showing small variations between saliva and urine samples, and is effective for measuring energy expenditure. ^{1 2 3 4 5}

Is it safe to measure water in breath and saliva for human energy expenditure?

The studies indicate that measuring water in breath and saliva using methods like the doubly labeled water technique is non-invasive and safe for humans, including children and normal subjects. Saliva sampling is preferred due to its ease and non-invasiveness, and the methods used have been validated for accuracy and precision. ^{2 4 6 7 8}

How does the treatment for measuring energy expenditure using water in breath and saliva differ from other treatments?

This treatment is unique because it uses the doubly labeled water method to measure energy expenditure through non-invasive saliva sampling, which is easier and less stressful than traditional methods that require blood or urine samples. ^{1 2 3 4 9}

Research Team

Edward L Melanson, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for healthy men and women aged 18-45 who are not pregnant or breastfeeding, do not have acute or chronic diseases like diabetes, heart or thyroid conditions, and are not obese (BMI > 30 kg/m2).

Inclusion Criteria

Healthy adult men and women, aged 18-45 yrs

Exclusion Criteria

You are currently pregnant or breastfeeding.

Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)

You have a higher than normal amount of body fat based on your weight and height (BMI > 30 kg/m2).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Evaluation of the natural abundances of 2H:1H and 18O:16O in urine, saliva, and breath of humans

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any changes in isotopic measurements post-baseline

4 weeks

Treatment Details

Interventions

• Feasibility of measuring 2H:1H and 18O:16O in saliva and breath

Trial Overview The study is testing the feasibility of measuring natural abundances of hydrogen and oxygen isotopes in saliva and breath to understand human energy expenditure better.

Participant Groups

Group I: Healthy adults (18-45 yrs.) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of bolus fluid intake on energy expenditure values as determined by the doubly labeled water method. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Validation of deuterium and oxygen18 in urine and saliva samples from children using on-line continuous-flow isotope ratio mass spectrometry. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Energy expenditure by doubly labeled water: validation in humans and proposed calculation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of isotope ratio mass spectrometry and cavity ring-down spectroscopy procedures and precision of the doubly labeled water method in different physiological specimens. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

In vivo isotope-fractionation factors and the measurement of deuterium- and oxygen-18-dilution spaces from plasma, urine, saliva, respiratory water vapor, and carbon dioxide. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Deuterium and oxygen-18 measurements on microliter samples of urine, plasma, saliva, and human milk. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Rapid measurement of deuterium content of breath following oral ingestion to determine body water. [2019]

8. England pubmed.ncbi.nlm.nih.gov

A rapid analytical technique for the determination of energy expenditure by the doubly labelled water method. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Total energy expenditure assessed by salivary doubly labelled water analysis and its relevance for short-term energy balance in humans. [2015]