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

• ClinicalTrials.gov Identifier: NCT04130724
• Recruitment Status: Enrolling by invitation
• Last Update Posted: October 17, 2019
• Sponsor: Readout, Inc.
• 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 *

• Hallberg SJ, McKenzie AL, Williams PT, Bhanpuri NH, Peters AL, Campbell WW, Hazbun TL, Volk BM, McCarter JP, Phinney SD, Volek JS. Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study. Diabetes Ther. 2018 Apr;9(2):583-612. doi: 10.1007/s13300-018-0373-9. Epub 2018 Feb 7. Erratum in: Diabetes Ther. 2018 Mar 5;:.
• Bhanpuri NH, Hallberg SJ, Williams PT, McKenzie AL, Ballard KD, Campbell WW, McCarter JP, Phinney SD, Volek JS. Cardiovascular disease risk factor responses to a type 2 diabetes care model including nutritional ketosis induced by sustained carbohydrate restriction at 1 year: an open label, non-randomized, controlled study. Cardiovasc Diabetol. 2018 May 1;17(1):56. doi: 10.1186/s12933-018-0698-8.
• Evert AB, Dennison M, Gardner CD, Garvey WT, Lau KHK, MacLeod J, Mitri J, Pereira RF, Rawlings K, Robinson S, Saslow L, Uelmen S, Urbanski PB, Yancy WS Jr. Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report. Diabetes Care. 2019 May;42(5):731-754. doi: 10.2337/dci19-0014. Epub 2019 Apr 18. Review.
• Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.
• Van Gaal L, Scheen A. Weight management in type 2 diabetes: current and emerging approaches to treatment. Diabetes Care. 2015 Jun;38(6):1161-72. doi: 10.2337/dc14-1630. Review.
• Boden G, Sargrad K, Homko C, Mozzoli M, Stein TP. Effect of a low-carbohydrate diet on appetite, blood glucose levels, and insulin resistance in obese patients with type 2 diabetes. Ann Intern Med. 2005 Mar 15;142(6):403-11.
• Shimazu T, Hirschey MD, Newman J, He W, Shirakawa K, Le Moan N, Grueter CA, Lim H, Saunders LR, Stevens RD, Newgard CB, Farese RV Jr, de Cabo R, Ulrich S, Akassoglou K, Verdin E. Suppression of oxidative stress by β-hydroxybutyrate, an endogenous histone deacetylase inhibitor. Science. 2013 Jan 11;339(6116):211-4. doi: 10.1126/science.1227166. Epub 2012 Dec 6.
• Anderson JC. Measuring breath acetone for monitoring fat loss: Review. Obesity (Silver Spring). 2015 Dec;23(12):2327-34. doi: 10.1002/oby.21242. Epub 2015 Nov 2. Review.
• Musa-Veloso K, Likhodii SS, Cunnane SC. Breath acetone is a reliable indicator of ketosis in adults consuming ketogenic meals. Am J Clin Nutr. 2002 Jul;76(1):65-70.

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

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