Placebo - ControlNCT06909331
Accuracy of Current Techniques in Quantifying Ketone Levels
A study testing Exogenous ketone salt in people with Placebo - Control and Exogenous Ketone Salt, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this study is to determine the accuracy of current measuring techniques used to detect physiological ketone levels. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Placebo - Control, Exogenous Ketone Salt
- What is being tested?
- Exogenous ketone salt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 15 Dec 2019
- Phase
- Interventional
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years
Who cannot join
- taking medications that affect blood pressure, insulin, or renal function, having meta-bolic syndrome factors such as type 2 diabetes, being pregnant, and/or indicating a pre-existing health condition on the health history questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the accuracy of current measuring techniques used to detect physiological ketone levels.
- Conditions
- Placebo - Control, Exogenous Ketone Salt
- Being tested
- Exogenous ketone salt, Placebo drink solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exogenous ketone saltDietary supplement
Exogenous ketone salt supplement will be taken once to determine acute circulating levels of beta-hydroxybuyrate and acetoacetate compared to a control supplement.
Placebo drink solutionDietary supplement
Participants consumed a placebo drink that was flavor, color and calorie matched to the experimental drink.
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | They were provided a placebo drink that was color, calorie and flavor-matched to the experimental drink. Receives: Dietary Supplement: Placebo drink solution |
| Experimental supplement | Experimental | They were provided an ketone salt drink. Receives: Dietary Supplement: Exogenous ketone salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating beta-hydroxybutyrate
Circulating beta-hydroxybutyrate levels measured by ketone meters and GC/MS
Measured: 30 minutes after consuming the drink
Circulating acetoacetate levels
Measured: 30 minutes after consuming the drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start15 Jan 2019
- Primary completion30 May 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placebo - ControlStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909331
- Sponsor's protocol ID
- IRBnet: 1317538
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Current Techniques in Quantifying Ketone Levels
- ClinicalTrials.gov ID
- NCT06909331
- Acronym / sponsor ID
- IRBnet: 1317538
- Conditions
- Placebo - Control, Exogenous Ketone Salt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 3 Apr 2025 (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 purpose of this study is to determine the accuracy of current measuring techniques used to detect physiological ketone levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drink solutionThey were provided a placebo drink that was color, calorie and flavor-matched to the experimental drink. |
| Experimental supplement | Experimental | Dietary Supplement: Exogenous ketone saltThey were provided an ketone salt drink. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-35 years
Key exclusion criteria (1 listed)
- taking medications that affect blood pressure, insulin, or renal function, having meta-bolic syndrome factors such as type 2 diabetes, being pregnant, and/or indicating a pre-existing health condition on the health history questionnaire
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 |
|---|---|---|
| Exogenous ketone saltExogenous ketone salt supplement will be taken once to determine acute circulating levels of beta-hydroxybuyrate and acetoacetate compared to a control supplement. | Dietary supplement | Experimental supplement |
| Placebo drink solutionParticipants consumed a placebo drink that was flavor, color and calorie matched to the experimental drink. | Dietary supplement | Placebo drink |
Primary outcome
Circulating beta-hydroxybutyrate
Time frame: 30 minutes after consuming the drink
Circulating beta-hydroxybutyrate levels measured by ketone meters and GC/MS
Circulating acetoacetate levels
Time frame: 30 minutes after consuming the drink
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 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Placebo - Control
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
Microscopic Colitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exogenous ketone salt in people with Placebo - Control and Exogenous Ketone Salt, run by Augusta University 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 1 inclusion and 1 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 3 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
Circulating beta-hydroxybutyrate (time frame: 30 minutes after consuming the drink). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.