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Completed

NCT Number: NCT04130724

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

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

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Key information

Conditions

Ketogenic Dieting Acid-Base Imbalance Acidosis Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Emerging Technologies

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood ketone testing

Diagnostic Test

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.

Breath ketone testing

Diagnostic Test

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Readout, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2019
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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