NCT04130724CompletedNot Applicable
Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status and Comparison to Blood Ketone Testing
Readout, Inc.1 site in 1 country21 target enrollmentStarted: October 16, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Correlation between breath acetone (BrAce) and blood beta-hydroxybutyrate (BHB) concentrations
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
- Reliability of the Readout breath acetone device(2 weeks)
Investigators
Study Sites (1)
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