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Comparison Between Breath Acetone and Blood Beta-Hydroxybutyrate

Relationship Among Breath Acetone, Blood Beta-Hydroxybutyrate, and Blood Glucose

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03299543
Enrollment
61
Registered
2017-10-03
Start date
2017-09-12
Completion date
2018-02-28
Last updated
2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketosis

Keywords

beta-hydroxybutyrate, breath acetone

Brief summary

Subjects will provide blood and breath samples to evaluate the relationship between breath acetone and two blood-bound species: beta-hydroxybutyrate and glucose. Subjects will be asked to provide breath and blood samples at a baseline visit and second optional visit. The two visits will be spaced approximately 3 hours apart.

Detailed description

The LEVL device (Medamonitor, Seattle, WA) provides users a method for assessing their own rate of fat metabolism. The LEVL device measures the concentration acetone in breath that the scientific literature has shown to correlate to the rate of fat metabolism. Typically, the body uses glucose to meet its metabolic energy requirements. If needed, the body can shift from using glucose to using fat. Many different scenarios can cause this shift. Exercise can deplete accessible carbohydrate stores causing the body to use fats for energy production. Dietary changes that cause fat intake to increase and carbohydrate intake to decrease will alter metabolism to efficiently utilize the change in nutrients. In all of these scenarios, the body reduces it utilization of carbohydrates and, thus, shifts to using fats for energy production. When the body uses fats as an energy substrate, some of these fat molecules are converted by the liver into acetoacetate, a ketone body. By enzymatic action, acetoacetate (AcAc) can be converted into beta-hydroxybutyrate (BOHB). The same enzyme can generate AcAc from BOHB. Additionally, acetoacetate can convert spontaneously into acetone which, due to its small size and highly water solubility, can readily appear in the breath. Currently, measurement of BOHB in blood is the gold standard for assessing ketone body concentration, also known as ketosis. BOHB measurement requires an invasive finger puncture to obtain blood and a costly (\ $5 / test) assay. Because acetone (BrAce) is a sister ketone body to BOHB, breath acetone may be used to assess ketosis and replace the measurement of BOHB. Data in the scientific literature has shown BrAce to correlate with BOHB. Inferring BOHB concentrations from measurement of BrAce using LEVL is less invasive and is potentially less costly. Reports have suggested that breath acetone is inversely correlated to blood sugar. However, others have suggested no relationship between the two species. If a relationship does exist, measurement of breath acetone could be used as a surrogate measure for blood sugar, a common assay used by individuals with diabetes. In this study, subjects will provide blood and breath samples evaluate the relationship between breath acetone and two blood-bound species: BOHB and glucose. Subjects may be asked to provide breath and blood samples at two different times (i.e., visits) spaced approximately 3 hours apart. The second visit is not required for participation in the study (i.e., optional).

Interventions

DEVICELEVL (Medamonitor)

Subjects will provide duplicate breath samples to the LEVL device for analysis of breath acetone

Sponsors

Medamonitor
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

1\. Subject must complete the consent process

Exclusion criteria

1. Subjects with severe lung disease which would prevent them from providing a breath sample through a large bore tube (e.g., large drinking straw) 2. Subjects with diabetes (Type 1 or Type 2) 3. Subjects who are routinely exposed to paints, paint thinners, gasoline, varnishes, glues, dry cleaning solvents, or industrial cleaning products 4. Daily smoker of cigarettes, e-cigarettes, or marijuana 5. Abstain from alcohol over the prior 24 hours 6. Refrain from consumption of large amounts of garlic

Design outcomes

Primary

MeasureTime frameDescription
Breath acetone concentration (ppm) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression.Through study completion, 4 monthsBoth individual and average group measurements will be compared

Secondary

MeasureTime frameDescription
Breath acetone concentration (ppm) will be compared against blood glucose concentration (mg/dL). The following methods may be used: summary statistics, plotting, and linear regression.Through study completion, 4 monthsBoth individual and average group measurements will be compared
Blood glucose concentration (mg/dL) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression.Through study completion, 4 monthsBoth individual and average group measurements will be compared

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026