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

Completed

Conditions studied: Ketogenic Dieting, Ketosis

In brief

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

Key facts

Study ID

NCT04130724

Run by

Readout, Inc.

People needed

21

Starts

2019-10-16

Expected to finish

2019-11-30

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Emerging Technologies — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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