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

NCT04130724 | Completed FDA Device

• 1 other identifier: RO-0001
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketogenic Dieting; Ketosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reliability of the Readout breath acetone device

  2 weeks

Other Outcomes (3)

• Utility of a single ketone measurement compared to multiple measurements throughout the day

  2 weeks

• Time dynamics of breath acetone compared to blood beta-hydroxybutyrate

  2 weeks

• Full-day ketone exposure as measured by breath acetone and blood beta-hydroxybutyrate

  2 weeks

Study Arms (2)

Ketogenic diet

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

High-carbohydrate diet

Subjects consuming a high carbohydrate (\>100g carbohydrate per day) diet.

Diagnostic Test: Blood ketone testing; Diagnostic Test: Breath ketone testing

Interventions

Blood ketone testing DIAGNOSTIC_TEST

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.

High-carbohydrate diet; Ketogenic diet

Breath ketone testing DIAGNOSTIC_TEST

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.

High-carbohydrate diet; Ketogenic diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are interested in the ketogenic diet or in tracking their ketones.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Readout, Inc.: lead

Study Sites (1)

Center for Emerging Technologies

St Louis, Missouri, 63108, United States

Location

Related Publications (9)

• 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.

  PMID: 29417495 BACKGROUND

• 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.

  PMID: 29712560 BACKGROUND

• 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. No abstract available.

  PMID: 31000505 BACKGROUND

• 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. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 25998297 BACKGROUND

• 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. doi: 10.7326/0003-4819-142-6-200503150-00006.

  PMID: 15767618 BACKGROUND

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

  PMID: 23223453 BACKGROUND

• 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.

  PMID: 26524104 BACKGROUND

• 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. doi: 10.1093/ajcn/76.1.65.

  PMID: 12081817 BACKGROUND

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• James McCarter, MD, PhD

  Readout, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 17, 2019
• Study Start: October 16, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

US (1)