Ketogenic DietingNCT04130724
Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
An observational study of Ketogenic Dieting and Ketosis, run by Readout, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Dieting, Ketosis
- What is being tested?
- Blood ketone testing and Breath ketone testing
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who are interested in the ketogenic diet or in tracking their ketones.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Emerging Technologies
St Louis, Missouri, 63108
About this study
Official title: Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status and Comparison to Blood Ketone Testing
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
- Being tested
- Blood ketone testing, Breath ketone testing
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ketone testingDiagnostic test
Also called Blood ketone testing using the Abbott Precision Xtra meter.
Ketone testing will be done using a blood beta-hydroxybutyrate (BHB) test at least five (5) times per day.
Breath ketone testingDiagnostic test
Also called Breath ketone testing using the Readout breath acetone device.
Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Subjects consuming either a ketogenic (<30g carbohydrate per day) or a low-carb (<100g carbohydrate per day) diet. Receives: Diagnostic Test: Blood ketone testing; Diagnostic Test: Breath ketone testing | |
| High-carbohydrate diet | Subjects consuming a high carbohydrate (>100g carbohydrate per day) diet. Receives: Diagnostic Test: Blood ketone testing; Diagnostic Test: Breath ketone testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start16 Oct 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ketogenic DietingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Readout, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James McCarter, MD, PhD, Principal investigator, Readout, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130724
- Sponsor's protocol ID
- RO-0001
- Status last verified
- Dec 2019
- First submitted
- 14 Oct 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 29417495Bhanpuri 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.
PubMed 29712560Evert 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.
PubMed 31000505Knowler 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.
PubMed 11832527Van 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.
PubMed 25998297Boden 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.
PubMed 15767618Shimazu 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.
PubMed 23223453Anderson 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.
PubMed 26524104Musa-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.
PubMed 12081817
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status and Comparison to Blood Ketone Testing
- ClinicalTrials.gov ID
- NCT04130724
- Acronym / sponsor ID
- RO-0001
- Conditions
- Ketogenic Dieting, Ketosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Readout, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | – | Diagnostic Test: Blood ketone testing, Diagnostic Test: Breath ketone testingSubjects consuming either a ketogenic (<30g carbohydrate per day) or a low-carb (<100g carbohydrate per day) diet. |
| High-carbohydrate diet | – | Diagnostic Test: Blood ketone testing, Diagnostic Test: Breath ketone testingSubjects consuming a high carbohydrate (>100g carbohydrate per day) diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are interested in the ketogenic diet or in tracking their ketones.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood ketone testingAlso: Blood ketone testing using the Abbott Precision Xtra meter.Ketone testing will be done using a blood beta-hydroxybutyrate (BHB) test at least five (5) times per day. | Diagnostic test | High-carbohydrate diet, Ketogenic diet |
| Breath ketone testingAlso: Breath ketone testing using the Readout breath acetone device.Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day. | Diagnostic test | High-carbohydrate diet, Ketogenic diet |
Primary outcome
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.
1 secondary outcome
Reliability of the Readout breath acetone device
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 29417495Hallberg 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.
- Background: PubMed 29712560Bhanpuri 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.
- Background: PubMed 31000505Evert 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.
- Background: PubMed 11832527Knowler 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.
- Background: PubMed 25998297Van 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.
- Background: PubMed 15767618Boden 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.
- Background: PubMed 23223453Shimazu 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.
- Background: PubMed 26524104Anderson 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.
- Background: PubMed 12081817Musa-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.
- Individual participant dataSharing planned: Undecided
Related trials for Ketogenic Dieting
Recruiting
Ketogenic Diet and Diabetes Demonstration Project
Type 2 Diabetes, PreDiabetes
RecruitingPhase 3
Ketogenic Diet for New-Onset Absence Epilepsy
Absence Epilepsy, Ketogenic Dieting
Active, not recruitingPhase 2/3
Effect of Nutritional Ketosis on Alcohol Metabolism
Ketoses, Metabolic, Ketogenic Dieting
Recruiting
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Lymphedema, Ketogenic Dieting
Not yet recruiting
Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling
Schizophrenia, Schizophrenia and Related Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James McCarter, MD, PhD principal investigator
Readout, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ketogenic Dieting and Ketosis, run by Readout, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between breath acetone (BrAce) and blood beta-hydroxybutyrate (BHB) concentrations (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130724, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.