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

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

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

Conditions
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Ketogenic Dieting, Ketosis

Intervention / Treatment
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* Diagnostic Test: Blood ketone testing
* Diagnostic Test: Breath ketone testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between breath acetone (BrAce) and blood beta-hydroxybutyrate (BHB) concentrations | 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 | 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 |