Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status

December 14, 2019 updated by: Readout, Inc.

Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status and Comparison to Blood Ketone Testing

The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Center for Emerging Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals who are interested in the ketogenic diet or in tracking their ketones.

Description

Inclusion Criteria:

  • Ketogenic diet cohort: currently following a ketogenic or low-carbohydrate diet defined as less than 30 grams per day (ketogenic) or less than 100 grams per day (low-carbohydrate) as estimated by the individual. Subjects must have been following the diet before the beginning of the study period and must continue with the diet throughout the duration of the trial.
  • High-carbohydrate diet cohort: currently following a diet that does not restrict dietary carbohydrate. Carbohydrate consumption should be greater than 100 grams per day as estimated by the individual. Subjects must have been following the diet before the study period and must continue with the diet throughout the duration of the trial.

Exclusion Criteria:

  • Type-1 diabetes
  • Insulin-dependent type-2 diabetes
  • History of diabetic ketoacidosis
  • Currently taking Warfarin or other blood thinners
  • Currently taking a sodium-glucose cotransporter-2 (SGLT2) inhibitor
  • Currently taking Disulfiram
  • Unwilling to maintain their diet during the study period
  • Unwilling to test blood and breath ketones five times per day
  • Non-English speaking
  • Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ketogenic diet
Subjects consuming either a ketogenic (<30g carbohydrate per day) or a low-carb (<100g carbohydrate per day) diet.
Diagnostic test: Blood ketone testing
Ketone testing will be done using a blood beta-hydroxybutyrate (BHB) test at least five (5) times per day.
Other Names:
  • Blood ketone testing using the Abbott Precision Xtra meter.
Diagnostic test: Breath ketone testing
Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day.
Other Names:
  • Breath ketone testing using the Readout breath acetone device.
High-carbohydrate diet
Subjects consuming a high carbohydrate (>100g carbohydrate per day) diet.
Diagnostic test: Blood ketone testing
Ketone testing will be done using a blood beta-hydroxybutyrate (BHB) test at least five (5) times per day.
Other Names:
  • Blood ketone testing using the Abbott Precision Xtra meter.
Diagnostic test: Breath ketone testing
Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day.
Other Names:
  • Breath ketone testing using the Readout breath acetone device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between breath acetone (BrAce) and blood beta-hydroxybutyrate (BHB) concentrations
Time Frame: 2 weeks
Blood BHB and BrAce measurements will be taken simultaneously during at least five (5) measurement sessions each day. After aggregating data from all study participants, the correlation between these two measurements will be determined using regression analysis.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of the Readout breath acetone device
Time Frame: 2 weeks
Multiple BrAce measurements will be taken during each measurement session using the Readout BrAce device and repeatability will be analyzed using alpha reliability coefficients.
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of a single ketone measurement compared to multiple measurements throughout the day
Time Frame: 2 weeks
The utility of a single BrAce measurement compared to multiple measurements throughout the day will be assessed by comparing a single measurement for a given user with the time-weighted average of all measurements taken that same day. The probability that a single measurement differs from the time-weighted average of all measurements during the same day will be computed for various difference thresholds.
2 weeks
Time dynamics of breath acetone compared to blood beta-hydroxybutyrate
Time Frame: 2 weeks
The time dynamics of blood BHB versus BrAce will be explored by performing a correlation calculation between the two measurement methods for various time shifts.
2 weeks
Full-day ketone exposure as measured by breath acetone and blood beta-hydroxybutyrate
Time Frame: 2 weeks
The full-day ketone exposure as measured by BrAce will be compared with the full-day ketone exposure as measured by blood BHB (12 AM on day 1 to 12 AM on day 2) by first performing linear interpolation between data points on a given day and then calculating the daily area under the curve (AUC) for BrAce and blood BHB. The correlation between blood and breath AUC will be determined by performing regression analysis.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Readout, Inc.

Investigators

  • Principal Investigator: James McCarter, MD, PhD, Readout, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 14, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RO-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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