Ketogenic Dieting, Ketosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTBlood ketone testing
Ketone testing will be done using a blood beta-hydroxybutyrate (BHB) test at least five (5) times per day.
DIAGNOSTIC_TESTBreath ketone testing
Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day.
Sponsors
Readout, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between breath acetone (BrAce) and blood beta-hydroxybutyrate (BHB) concentrations | 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
| Measure | Time frame | Description |
|---|---|---|
| Reliability of the Readout breath acetone device | 2 weeks | Multiple BrAce measurements will be taken during each measurement session using the Readout BrAce device and repeatability will be analyzed using alpha reliability coefficients. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Utility of a single ketone measurement compared to multiple measurements throughout the day | 2 weeks | 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 dynamics of breath acetone compared to blood beta-hydroxybutyrate | 2 weeks | 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. |
| Full-day ketone exposure as measured by breath acetone and blood beta-hydroxybutyrate | 2 weeks | 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. |
Countries
United States
Outcome results
None listed