An observational study in Ketogenic Dieting and Ketosis, sponsored by Readout, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by Readout, Inc. · Observational
The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.
181 studies on the registry are indexed under Ketosis; 37 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 31 observational studies indexed under Ketosis.
Browse Ketosis studies →This is the only study on the registry with Readout, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Individuals who are interested in the ketogenic diet or in tracking their ketones.
Exclusion Criteria:
Subjects consuming either a ketogenic (\<30g carbohydrate per day) or a low-carb (\<100g carbohydrate per day) diet.
Diagnostic Test: Blood ketone testing · Diagnostic Test: Breath ketone testing
Subjects consuming a high carbohydrate (\>100g carbohydrate per day) diet.
Diagnostic Test: Blood ketone testing · Diagnostic Test: Breath ketone testing
Ketone testing will be done using a blood beta-hydroxybutyrate (BHB) test at least five (5) times per day.
Also known as: Blood ketone testing using the Abbott Precision Xtra meter.
Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day.
Also known as: Breath ketone testing using the Readout breath acetone device.
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
Utility of a single ketone measurement compared to multiple measurements throughout the day
The utility of a single BrAce measurement compared to multiple measurements throughout the day will be assessed by comparing a single measurement for a given user with the time-weighted average of all measurements taken that same day. The probability that a single measurement differs from the time-weighted average of all measurements during the same day will be computed for various difference thresholds.
Time frame: 2 weeks
Time dynamics of breath acetone compared to blood beta-hydroxybutyrate
The time dynamics of blood BHB versus BrAce will be explored by performing a correlation calculation between the two measurement methods for various time shifts.
Time frame: 2 weeks
Full-day ketone exposure as measured by breath acetone and blood beta-hydroxybutyrate
The full-day ketone exposure as measured by BrAce will be compared with the full-day ketone exposure as measured by blood BHB (12 AM on day 1 to 12 AM on day 2) by first performing linear interpolation between data points on a given day and then calculating the daily area under the curve (AUC) for BrAce and blood BHB. The correlation between blood and breath AUC will be determined by performing regression analysis.
Time frame: 2 weeks
Plan to share: Undecided
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.