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

Ketosis Clinical Trial

Official title:

Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status and Comparison to Blood Ketone Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130724
• Other study ID #: RO-0001
• Status: Completed
• Start date: October 16, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Readout, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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.
• Breath ketone testing
Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day.

Locations

Country	Name	City	State
United States	Center for Emerging Technologies	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Readout, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;:. — View Citation

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. — View Citation

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. — View Citation

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 ß-hydroxybutyrate, an endogenous histone deacetylase inhibitor. Science. 2013 Jan 11;339(6116):211-4. doi: 10.1126/science.1227166. Epub 2012 Dec 6. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	2 weeks
Other	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.	2 weeks
Other	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.	2 weeks
Primary	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.	2 weeks
Secondary	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.	2 weeks