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

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ClinicalTrials.gov Identifier: NCT04130724
Recruitment Status : Enrolling by invitation
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Readout, Inc.

Tracking Information
First Submitted Date October 14, 2019
First Posted Date October 17, 2019
Last Update Posted Date October 17, 2019
Estimated Study Start Date October 16, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 15, 2019)
Reliability of the Readout breath acetone device [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2019)
  • Utility of a single ketone measurement compared to multiple measurements throughout the day [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
Official Title Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status and Comparison to Blood Ketone Testing
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals who are interested in the ketogenic diet or in tracking their ketones.
Condition
  • Ketogenic Dieting
  • Ketosis
Intervention
  • Diagnostic Test: Blood ketone testing
    Ketone testing will be done using a blood beta-hydroxybutyrate (BHB) test at least five (5) times per day.
    Other Name: Blood ketone testing using the Abbott Precision Xtra meter.
  • Diagnostic Test: Breath ketone testing
    Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day.
    Other Name: Breath ketone testing using the Readout breath acetone device.
Study Groups/Cohorts
  • Ketogenic diet
    Subjects consuming either a ketogenic (<30g carbohydrate per day) or a low-carb (<100g carbohydrate per day) diet.
    Interventions:
    • Diagnostic Test: Blood ketone testing
    • Diagnostic Test: Breath ketone testing
  • High-carbohydrate diet
    Subjects consuming a high carbohydrate (>100g carbohydrate per day) diet.
    Interventions:
    • Diagnostic Test: Blood ketone testing
    • Diagnostic Test: Breath ketone testing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 15, 2019)
24
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04130724
Other Study ID Numbers RO-0001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Readout, Inc.
Study Sponsor Readout, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: James McCarter, MD, PhD Readout, Inc.
PRS Account Readout, Inc.
Verification Date October 2019