KetosisSTAK-VKMNCT05924295
Variations in Ketone Metabolism
A study testing Ketone Supplement, Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale and Blood Draw in people with Ketosis, run by Ohio State University at 2 sites in United States.
Trial summary
This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketosis
- What is being tested?
- Ketone Supplement, Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale and Blood Draw
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jun 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 20 - 70 years
- Participant is willing and able to comply with all study procedures including the following prior to Test Day: fasting (>10 h; water only), no alcohol (>24 h), no exercise (>24 h), no acute illness and controlled feeding before the Test Day, maintain diet, exercise, medication, and supplement habits throughout the study.
- Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.
Who cannot join
- Participant follows a low-carbohydrate diet (<30% energy from carbohydrate) or have used exogenous ketone supplements within 4-months of study participation.
- Participant has a Primary Care Physician diagnosed history or presence of uncontrolled and/or clinically important hypertension (blood pressure >150/95 mmHg), pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders.
- Participant has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages, including soy and milk protein, wheat, shellfish, fin fish, eggs, tree nuts or peanuts (production facility handles nuts).
- Participant has unstable use of a medication or supplement that the Investigator considers may affect the outcomes of the trial.
- Consumption of alcohol more than 3 drinks per day or more than 18 drinks per week.
- Consumption of tobacco.
Show all 11Show fewer
- Consumption of cannabis.
- Participant is currently in another research study or has been in the 14 days before screening.
- Participant has had a blood draw or donation in the last 8 weeks.
- Participant has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study beverage [e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the Investigator), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the Investigator, medication managed reflux and/or clinically important lactose intolerance].
- Participant has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Jeff Volek, PhD, 614-688-1701, volek.1@osu.edu
Madison Kackley, PhD, 614-247-9650, kackley.19@osu.edu
- Recruiting
The Buck Institute
Novato, California, 94945
Brianna Stubbs, DPhil, 415-209-2072, bstubbs@buckinstitute.org
About this study
Official title: Strategies to Augment Ketosis- Variations in Ketone Metabolism
This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes. However, two striking experiments using identical, body weight adjusted KE doses in healthy and obese individuals found that BHB area under the curve (AUC) and removal was reduced by obesity and poor metabolic health. Similarly, ketone infusion experiments found that diabetes, obesity, and insulin resistance alter BHB metabolism. It is important to determine how obesity affects KE 'sensitivity' (i.e., breakdown and oxidation) because the increasing prevalence of obesity as a function of age. Age may be another important source of variation in ketone metabolism. The genes that control the ketone system are regulated by a cascade of transcription factors and hormones including PPARα and FGF21, which are themselves known to be affected by aging and dietary status, and the cellular protein sensor target of rapamycin (TOR). Aberrant hyperactivation of TOR with aging may reduce ketogenesis, while it was observed that a long-term ketogenic diet specifically up-regulated PPARα activity. Preliminary work revealed substantial changes across mouse lifespan in the expression of ketone-related genes in the liver such as Hmgcs2 (rate limiting for ketone production) and Bdh1 (rate limiting for BHB oxidation) between young, middle-aged, and old mice, with a nadir of gene expression in middle age before increasing again late in life. Substantial age differences were found in response to matched doses of oral KE in mice and in rats. These data may have important implications for treating people of different ages and for translating KE technologies into the Department of VA. Therefore, this project plans to study individual responses to KE ingestion across the lifespan, against the background of varying metabolic health
Read the detailed description
KEs could represent a practical STAK method that does not require any change in diet. However, there is a critical need to elucidate how KE metabolism varies between individuals to inform KE use in the field. This high impact project will contribute important knowledge that aims to develop next-generation KE molecules and formulations that are designed to meet the needs of operators at different points in their career. The long-term goal is to create evidence-based guidelines for deployment of KE compounds based on individual characteristics.This is an open label, one arm study to characterize the effects of age and metabolic health on ketone responsiveness. Enrollment will include a large group representing a range of ages and metabolic health status. N of 300 will be recruited and tested at the Physical Activity and Education services facility at the Ohio State University, Columbus, OH, and an N of 100 will be recruited and tested at the Buck Institute in Novato, California. Data/sample collection will include blood (capillary and whole venous blood) and study product tolerability.This study aims to recruit equal numbers of male and female participants between the ages of 20 to 70yr. Thus, recruitment will employ a balanced sample of men and women with a range of ages (equal representation in each of the 5 included decades; 20-29yr, 30-39yr, 40-49yr, 50-59yr, 60-70yr) and metabolic health via HbA1c clinical ranges (normal: <5.7, prediabetes: 5.7-6.4, diabetes: >6.4). Each participant must meet all the inclusion criteria and none of the exclusion criteria at screening in order to participate.
Participants that meet the initial qualifying criteria will visit the study center for a screening meeting. The participant and a member of the research team will meet in a private office to discuss the informed consent form. The informed consent form will be provided to the participant for their review, the study will be described in full detail and any questions the interested participant has will be encouraged and responded to. If they choose to participate in the study, they will be asked to sign the consent form providing written consent. The participant will be informed that even though they signed the consent form, their participation in the study is dependent on anthropometric measures and diet and medical questionnaire answers to determine if they meet the study criteria.
If the participant provides consent, they will be provided with questionnaires including Automated Self-administered 24-hour Dietary Assessment Tool (ASA24®),and medical history. All collected samples and data will be coded to maintain participant anonymity. Participants will be given a small volume of Study Product to screen for tolerance of the bitter tasting Study Product. Height, weight and body composition using bioelectrical impedance will also be measured. A1CNow+, Hba1c Blood monitor kit will be used to assess Hba1c score. Both body composition and Hba1c score to stratify participants to ensure various metabolic statuses are represented in the study population. The participant will then complete a 6 minutes Astrand Bike Test to determine the predicted VO2 Max. This test does not require fasting and uses only submaximal effort upon the participant to determine cardiometabolic status by an average heart rate at 6 minutes of pedaling at a moderate intensity. If the participant is eligible for the study and is still interested in participating then they will be scheduled to return to the study center for the testing visit.
Participants will report to the study center in the morning of the Test Day. Compliance with pre-test instructions (fasted > 10h, no alcohol >24h, no exercise >24h, consumed pre-test food) will be confirmed study staff. Participants will complete a baseline Beverage Tolerability Questionnaire (BTQ). Participants will be asked to completely void their bladder and a sample will be analyzed for hydration status. Participants with samples reading greater > 1.025 USG will be asked to drink 160z of water and retest again in 30 minutes. Participants will be provided with a container to void all urine during the study visit. This will be aliquoted for urine R-BHB analysis to assess the clearance of ketones in the body. A trained member of the study team will insert an IV cannula into a vein in the antecubital fossa to allow for repeated blood sampling. The cannula will be flushed with a small volume of saline after each sample withdrawal to maintain patency. At the same time as all whole blood samples, capillary blood samples will also be collected from a finger for real-time analysis of blood BHB and glucose concentration, using lancing device, commercially available test strips and a handheld monitor (KetoMojo, CA, USA).
Participants will then consume the C8 Ketone Diester Study Product. They will be given 5 minutes to consume the Product. After C8 Ketone Diester consumption, they will remain at the study center for ~4-5h, with blood sampling occurring at regular intervals (see Figure 2). A total of 7 whole blood samples (~8 mL each) will be collected each Test Day. Capillary blood samples will be collected at the same time as whole blood samples. At the 4th hour finger stick, participants whose capillary ketones levels have not returned to baseline will be asked to stay for a 5th hour to assess the complete metabolism of the study product. Participants will complete satiety questionnaires each hour, and will complete a BTQ at the end of the Test Day.
Participants will be asked to minimize ambulatory movement during the Test Day. Non caloric beverages (i.e., water) will be permitted ad libitum and intake volumes will be recorded. At the end of the Test Day, the IV cannula will be removed and a dressing will be applied to the cannula site. Participants will be given a snack to consume.
- Conditions
- Ketosis
- Being tested
- Ketone Supplement, Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale, Blood Draw, Urine Analysis
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone SupplementDietary supplement
Participants will be given 360mg/kg
Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scaleBehavioural
Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale will be administered at beginning and end of testing day to tests palatability of supplement
Blood DrawBiological
IV cannula will be inserted at the start of Test Day, and removed at the end of Test Day. Blood samples will be collected at 7 timepoints (possibly 1 more). Cannula will be flushed with a small volume of saline after each sample to maintain patency.
Urine AnalysisOther
Prior to consumption of the Study Product, participants will be asked to completely void bladder. And hydration status will be determined via urine specific gravity (USG) reporting <1.025. Urine passed after the ingestion of the study product will be collected in a plastic container; participants will be asked to void their bladder and collect urine at the end of the test day. The volume produced will be recorded at the end of the study and aliquots will be frozen and stored for future analysis
| Study group | Role | What they receive |
|---|---|---|
| C8 Ketone Supplement | Experimental | 360mg/kg of supplement will be given on a singular testing day. Receives: Dietary Supplement: Ketone Supplement; Behavioral: Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale; Biological: Blood Draw; Other: Urine Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary d-BHB
Difference in ketone appearance across metabolic statuses
Measured: 4 hours
Secondary outcomes (5)
Ketone Excretion
Changes in urine excretion analysis
Measured: up to ~5 hours
Satiety Visual Analogue Scale
We will use a 3-item visual analogue scale, that assesses hunger, fullness and desire to eat by participant's marking on a line anchored at either end with 'not at all' and 'extremely.' Distance along the line is measured in mm.
Measured: Up to 4 hours
Beverage tolerability questionnaire (BTQ)
Ten tolerability issues are included in the BTQ: gas/flatulence, nausea, vomiting, abdominal cramping, stomach rumbling, burping, reflux (heartburn), diarrhea, headache, and dizziness. Participants are asked if the issue was present (pre- beverage - baseline) or had occurred since they took the study beverage (post-beverage - 4hours) at the following intensities: none, mild (awareness of symptoms but easily tolerated), moderate (discomfort enough to interfere with but not prevent daily activity) or severe (unable to perform usual activity). These correspond to scores of 0-3, respectively for each issue, giving a maximal composite score, defined as the sum of the ten items, of 30.
Measured: up to 4 hours
Insulin
Differences in blood hormones insulin after supplementation will be analyzed using commercially available ELISA assay kits (Cayman Chemical, USA).
Measured: up to 4 hours
Capillary glucose concentrations
Differences in capillary glucose levels.
Measured: up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start20 Jun 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetosisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Buck Institute for Research on Aging
- Responsible party
- Sponsor
- Investigators
- Jeff Volek, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924295
- Sponsor's protocol ID
- 2022H0292
- Other IDs
- CDMRP-PR212399-B
- Acronym
- STAK-VKM
- Status last verified
- May 2025
- First submitted
- 20 Jun 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Augment Ketosis- Variations in Ketone Metabolism
- ClinicalTrials.gov ID
- NCT05924295
- Acronym / sponsor ID
- STAK-VKM / 2022H0292
- Conditions
- Ketosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Buck Institute for Research on Aging
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Jun 2023 (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.
This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes. However, two striking experiments using identical, body weight adjusted KE doses in healthy and obese individuals found that BHB area under the curve (AUC) and removal was reduced by obesity and poor metabolic health. Similarly, ketone infusion experiments found that diabetes, obesity, and insulin resistance alter BHB metabolism. It is important to determine how obesity affects KE 'sensitivity' (i.e., breakdown and oxidation) because the increasing prevalence of obesity as a function of age. Age may be another important source of variation in ketone metabolism. The genes that control the ketone system are regulated by a cascade of transcription factors and hormones including PPARα and FGF21, which are themselves known to be affected by aging and dietary status, and the cellular protein sensor target of rapamycin (TOR). Aberrant hyperactivation of TOR with aging may reduce ketogenesis, while it was observed that a long-term ketogenic diet specifically up-regulated PPARα activity. Preliminary work revealed substantial changes across mouse lifespan in the expression of ketone-related genes in the liver such as Hmgcs2 (rate limiting for ketone production) and Bdh1 (rate limiting for BHB oxidation) between young, middle-aged, and old mice, with a nadir of gene expression in middle age before increasing again late in life. Substantial age differences were found in response to matched doses of oral KE in mice and in rats. These data may have important implications for treating people of different ages and for translating KE technologies into the Department of VA. Therefore, this project plans to study individual responses to KE ingestion across the lifespan, against the background of varying metabolic health
Detailed description
KEs could represent a practical STAK method that does not require any change in diet. However, there is a critical need to elucidate how KE metabolism varies between individuals to inform KE use in the field. This high impact project will contribute important knowledge that aims to develop next-generation KE molecules and formulations that are designed to meet the needs of operators at different points in their career. The long-term goal is to create evidence-based guidelines for deployment of KE compounds based on individual characteristics.This is an open label, one arm study to characterize the effects of age and metabolic health on ketone responsiveness. Enrollment will include a large group representing a range of ages and metabolic health status. N of 300 will be recruited and tested at the Physical Activity and Education services facility at the Ohio State University, Columbus, OH, and an N of 100 will be recruited and tested at the Buck Institute in Novato, California. Data/sample collection will include blood (capillary and whole venous blood) and study product tolerability.This study aims to recruit equal numbers of male and female participants between the ages of 20 to 70yr. Thus, recruitment will employ a balanced sample of men and women with a range of ages (equal representation in each of the 5 included decades; 20-29yr, 30-39yr, 40-49yr, 50-59yr, 60-70yr) and metabolic health via HbA1c clinical ranges (normal: <5.7, prediabetes: 5.7-6.4, diabetes: >6.4). Each participant must meet all the inclusion criteria and none of the exclusion criteria at screening in order to participate.
Participants that meet the initial qualifying criteria will visit the study center for a screening meeting. The participant and a member of the research team will meet in a private office to discuss the informed consent form. The informed consent form will be provided to the participant for their review, the study will be described in full detail and any questions the interested participant has will be encouraged and responded to. If they choose to participate in the study, they will be asked to sign the consent form providing written consent. The participant will be informed that even though they signed the consent form, their participation in the study is dependent on anthropometric measures and diet and medical questionnaire answers to determine if they meet the study criteria.
If the participant provides consent, they will be provided with questionnaires including Automated Self-administered 24-hour Dietary Assessment Tool (ASA24®),and medical history. All collected samples and data will be coded to maintain participant anonymity. Participants will be given a small volume of Study Product to screen for tolerance of the bitter tasting Study Product. Height, weight and body composition using bioelectrical impedance will also be measured. A1CNow+, Hba1c Blood monitor kit will be used to assess Hba1c score. Both body composition and Hba1c score to stratify participants to ensure various metabolic statuses are represented in the study population. The participant will then complete a 6 minutes Astrand Bike Test to determine the predicted VO2 Max. This test does not require fasting and uses only submaximal effort upon the participant to determine cardiometabolic status by an average heart rate at 6 minutes of pedaling at a moderate intensity. If the participant is eligible for the study and is still interested in participating then they will be scheduled to return to the study center for the testing visit.
Participants will report to the study center in the morning of the Test Day. Compliance with pre-test instructions (fasted > 10h, no alcohol >24h, no exercise >24h, consumed pre-test food) will be confirmed study staff. Participants will complete a baseline Beverage Tolerability Questionnaire (BTQ). Participants will be asked to completely void their bladder and a sample will be analyzed for hydration status. Participants with samples reading greater > 1.025 USG will be asked to drink 160z of water and retest again in 30 minutes. Participants will be provided with a container to void all urine during the study visit. This will be aliquoted for urine R-BHB analysis to assess the clearance of ketones in the body. A trained member of the study team will insert an IV cannula into a vein in the antecubital fossa to allow for repeated blood sampling. The cannula will be flushed with a small volume of saline after each sample withdrawal to maintain patency. At the same time as all whole blood samples, capillary blood samples will also be collected from a finger for real-time analysis of blood BHB and glucose concentration, using lancing device, commercially available test strips and a handheld monitor (KetoMojo, CA, USA).
Participants will then consume the C8 Ketone Diester Study Product. They will be given 5 minutes to consume the Product. After C8 Ketone Diester consumption, they will remain at the study center for ~4-5h, with blood sampling occurring at regular intervals (see Figure 2). A total of 7 whole blood samples (~8 mL each) will be collected each Test Day. Capillary blood samples will be collected at the same time as whole blood samples. At the 4th hour finger stick, participants whose capillary ketones levels have not returned to baseline will be asked to stay for a 5th hour to assess the complete metabolism of the study product. Participants will complete satiety questionnaires each hour, and will complete a BTQ at the end of the Test Day.
Participants will be asked to minimize ambulatory movement during the Test Day. Non caloric beverages (i.e., water) will be permitted ad libitum and intake volumes will be recorded. At the end of the Test Day, the IV cannula will be removed and a dressing will be applied to the cannula site. Participants will be given a snack to consume.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C8 Ketone Supplement | Experimental | Dietary Supplement: Ketone Supplement, Behavioral: Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale, Biological: Blood Draw, Other: Urine Analysis360mg/kg of supplement will be given on a singular testing day. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 20 - 70 years
- Participant is willing and able to comply with all study procedures including the following prior to Test Day: fasting (>10 h; water only), no alcohol (>24 h), no exercise (>24 h), no acute illness and controlled feeding before the Test Day, maintain diet, exercise, medication, and supplement habits throughout the study.
- Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.
Key exclusion criteria (11 listed)
- Participant follows a low-carbohydrate diet (<30% energy from carbohydrate) or have used exogenous ketone supplements within 4-months of study participation.
- Participant has a Primary Care Physician diagnosed history or presence of uncontrolled and/or clinically important hypertension (blood pressure >150/95 mmHg), pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders.
- Participant has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages, including soy and milk protein, wheat, shellfish, fin fish, eggs, tree nuts or peanuts (production facility handles nuts).
- Participant has unstable use of a medication or supplement that the Investigator considers may affect the outcomes of the trial.
- Consumption of alcohol more than 3 drinks per day or more than 18 drinks per week.
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 |
|---|---|---|
| Ketone SupplementParticipants will be given 360mg/kg | Dietary supplement | C8 Ketone Supplement |
| Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scaleBeverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale will be administered at beginning and end of testing day to tests palatability of supplement | Behavioural | C8 Ketone Supplement |
| Blood DrawIV cannula will be inserted at the start of Test Day, and removed at the end of Test Day. Blood samples will be collected at 7 timepoints (possibly 1 more). Cannula will be flushed with a small volume of saline after each sample to maintain patency. | Biological | C8 Ketone Supplement |
| Urine AnalysisPrior to consumption of the Study Product, participants will be asked to completely void bladder. And hydration status will be determined via urine specific gravity (USG) reporting <1.025. Urine passed after the ingestion of the study product will be collected in a plastic container; participants will be asked to void their bladder and collect urine at the end of the test day. The volume produced will be recorded at the end of the study and aliquots will be frozen and stored for future analysis | Other | C8 Ketone Supplement |
Primary outcome
Capillary d-BHB
Time frame: 4 hours
Difference in ketone appearance across metabolic statuses
5 secondary outcomes
Ketone Excretion
Time frame: up to ~5 hours
Satiety Visual Analogue Scale
Time frame: Up to 4 hours
Beverage tolerability questionnaire (BTQ)
Time frame: up to 4 hours
Insulin
Time frame: up to 4 hours
Capillary glucose concentrations
Time frame: up to 5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- OSU Office of Responsible Research PracticesLink provided by the sponsor.
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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.
Jeff Volek, PhD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Supplement, Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale and Blood Draw in people with Ketosis, run by Ohio State University at 2 sites 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeff Volek, PhD (6146881701, volek.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary d-BHB (time frame: 4 hours). 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 14 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.