Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
NCT ID: NCT04130724
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
21 participants
OBSERVATIONAL
2019-10-16
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ketogenic diet
Subjects consuming either a ketogenic (\<30g carbohydrate per day) or a low-carb (\<100g carbohydrate per day) diet.
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.
High-carbohydrate diet
Subjects consuming a high carbohydrate (\>100g carbohydrate per day) diet.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Readout, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James McCarter, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Readout, Inc.
Locations
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Center for Emerging Technologies
St Louis, Missouri, United States
Countries
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References
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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.
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. No abstract available.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RO-0001
Identifier Type: -
Identifier Source: org_study_id