Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison Between Breath Acetone and Blood Beta-Hydroxybutyrate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299543
Recruitment Status : Completed
First Posted : October 3, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medamonitor

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.

Condition or disease Intervention/treatment
Ketosis Device: LEVL (Medamonitor)

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Among Breath Acetone, Blood Beta-Hydroxybutyrate, and Blood Glucose
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : February 16, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Acetone

Group/Cohort Intervention/treatment
Healthy adults
Healthy adults who are able to provide duplicate breath samples and pin-drop blood samples
Device: LEVL (Medamonitor)
Subjects will provide duplicate breath samples to the LEVL device for analysis of breath acetone




Primary Outcome Measures :
  1. Breath acetone concentration (ppm) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression. [ Time Frame: Through study completion, 4 months ]
    Both individual and average group measurements will be compared


Secondary Outcome Measures :
  1. 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. [ Time Frame: Through study completion, 4 months ]
    Both individual and average group measurements will be compared

  2. 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. [ Time Frame: Through study completion, 4 months ]
    Both individual and average group measurements will be compared



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299543


Locations
Layout table for location information
United States, Washington
Medamonitor, LLC
Seattle, Washington, United States, 98119
Sponsors and Collaborators
Medamonitor
Investigators
Layout table for investigator information
Principal Investigator: Joseph C Anderson, PhD Medamonitor
Layout table for additonal information
Responsible Party: Medamonitor
ClinicalTrials.gov Identifier: NCT03299543    
Other Study ID Numbers: LVL-0717
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medamonitor:
beta-hydroxybutyrate
breath acetone
Additional relevant MeSH terms:
Layout table for MeSH terms
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases