Status:
COMPLETED
Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
Lead Sponsor:
Readout, Inc.
Conditions:
Ketogenic Dieting
Ketosis
Eligibility:
All Genders
18+ years
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
- 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
- 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.
Key Trial Info
Start Date :
October 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04130724
Start Date
October 16 2019
End Date
November 30 2019
Last Update
December 17 2019
Active Locations (1)
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1
Center for Emerging Technologies
St Louis, Missouri, United States, 63108