Clinical trial NCT04130724: Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
Official title: Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status and Comparison to Blood Ketone Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ketogenic Dieting
Ketosis
Lead sponsor: Readout, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are interested in the ketogenic diet or in tracking their ketones.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between breath acetone (BrAce) and blood beta-hydroxybutyrate (BHB) concentrations
timeFrame: 2 weeks
Secondary outcomes:
measure: Reliability of the Readout breath acetone device
timeFrame: 2 weeks
Other outcomes:
measure: Utility of a single ketone measurement compared to multiple measurements throughout the day
timeFrame: 2 weeks
measure: Time dynamics of breath acetone compared to blood beta-hydroxybutyrate
timeFrame: 2 weeks
measure: Full-day ketone exposure as measured by breath acetone and blood beta-hydroxybutyrate
timeFrame: 2 weeks
Locations:
city: Saint Louis
country: United States
facility: Center for Emerging Technologies
state: Missouri
Study officials:
affiliation: Readout, Inc.
name: James McCarter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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