An interventional study of Ketone monoester and Placebo in Ketosis, sponsored by Central Jutland Regional Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Central Jutland Regional Hospital · Not applicable, Interventional, and Basic science
This study aims to address two key aspects. First, the suitability of selecting a specific sampling site for BHB measurement in patients and research, as well as potential differences between capillary and venous blood measurements. Additionally, the study will investigate the effects of ketosis on EPO concentrations, sex hormone levels, hemodynamic markers, and blood pressure.
This investigation will utilize blood samples collected from baseline and at Day 15, between which participants are exposed to intermittent ketosis or placebo in a randomized parallel design.
Aim and Perspective The primary objective of this study is to ascertain The agreement between estimates of beta-hydroxybutyrate (BHB) in capillary and venous blood and whether this agreement is influenced by the level of BHB.
The agreement in BHB measurements between finger and earlobe capillary samples. The agreement in BHB measurements between venous estimates obtained through a point-of-care device (KetoSure) and full blood estimates obtained through hydrophilic interaction liquid chromatography tandem mass spectrometry (HLCMS).
A central aim of the study is also to investigate The impact of ketosis on short-term and longer-term erythropoietin (EPO) levels.
The resulting effects of EPO on erythropoiesis and iron metabolism during a two-week period of intermittent ketosis.
The effects of ketosis on sex hormones including derived factors. The effects of ketosis on hemodynamic markers and blood pressure.
The study aims to determine the appropriateness of selecting a specific sampling site for BHB measurement in both patient care and research. Additionally, it seeks to identify any differences between BHB measurements from capillary and venous blood samples. The study will also examine the concordance between the KetoSure point-of-care-test (POCT) device and the established gold standard, offering insight into any discrepancies arising from electrochemical estimations and HLCMS.
Accurate BHB measurement is crucial in clinical and experimental settings. Firstly, precise BHB quantification can inform clinical decision-making for conditions such as suspected hyperinsulinemia, uncertain etiology hypoglycemia, and diabetic ketoacidosis. Secondly, given the extensive research on BHB inference and ketones in recent years, the credibility of these studies heavily hinges on the precision of measurements concerning sample type and sampling site selection.
During the randomized study period, the effects of ketosis on EPO concentrations, sex hormone levels, hemodynamic markers, and blood pressure measurements will be explored. These analyses will be conducted using blood samples collected from baseline through the acute study visit as well as on Day 15, when participants receive intermittent BHB ketone ester supplementation or matched placebo according to randomization.
Analytical approach Following a visual assessment of graphical linearity representation, differences will be calculated using the paired t-test, agreement determined using the Bland-Altman plot, and correlations assessed using Pearson's r. Further calculations will employ Lin's concordance correlation coefficient of absolute agreement. An analysis equivalent to repeated measurements ANOVA will be applied. No imputation of missing data will be conducted, and steps will be taken to ensure data completeness before participants leave the research facilities.
Sample Size and Power Calculation Given the absence of prior studies on BHB agreement data, our study's sample size calculations are based on relevant literature. Citing Boyd et al., and considering correlated glucose estimates, a sample size of 13 participants will provide sufficient statistical power (alpha = 0.05, beta = 20%) to detect a difference of 0.58 mM in glucose estimates between capillary and venous blood samples (SD = 0.68 mM). A sample size of 20 participants is justifiably required to detect a clinically significant difference of 1 mM (SD = 1.5) under the same parameters. Consequently, we will include 16 patients in our study.
Up to 150 mL of blood will be collected during the study, including repeated sampling through an indwelling catheter during acute testing and follow-up outpatient sampling at Day 15.
Purpose of Storage Biological samples will be stored at -80 °C for the duration of data collection and for 18 months thereafter to allow for batch analyses. A research biobank will be established for samples not analyzed immediately, with surplus material preserved for potential future research.
Handling of Patient Information Access to electronic health records is limited to laboratory results necessary for study analyses and is included in informed consent. Data will be pseudonymized during analysis. De-identification codes will be retained by the primary investigator.
Data Privacy and Sharing Data access is restricted to investigators until completion of final analyses. After anonymization, data may be shared upon reasonable request. Public data sharing is under consideration following publication.
Financial Information The study is investigator-initiated and funded through independent research funds within the Department of Internal Medicine, Regional Hospital Viborg. No investigators have financial interests in the intervention.
218 studies on the registry are indexed under Ketosis; 50 are open to participants now.
This study's enrollment of 16 is below the median of 20 across 190 interventional studies indexed under Ketosis.
Browse Ketosis studies →Central Jutland Regional Hospital is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ketosis (the condition being investigated) is obtained by ingestion of a ketone monoester
Dietary Supplement: Ketone monoester
The control arm is a drink matched in taste, volume, appearence, and viscosity to that of the active/experimental arm
Dietary Supplement: Placebo
Supraphysiological ketosis induced by ingestion of a ketone monoester dietary supplement administered intermittently during the randomized two-week intervention period.
Also known as: KetoneAid Ke4 Pro Ketone Ester
The placebo vehicle is matched to the ketosis intervention in the experimental arm with regards to taste, volume, viscosity, appearence, and packaging
Change in Venous Plasma Beta-hydroxybutyrate (BHB) From Baseline to Peak During Acute Ketosis Exposure
Venous plasma beta-hydroxybutyrate (BHB) concentration measured in mmol/L. The outcome represents the change from baseline (0 minutes) to the maximum observed BHB concentration during the acute ketosis exposure.
Time frame: Baseline (0 minutes) to peak concentration during acute ketosis exposure (0-180 minutes)
Serum Erythropoietin Concentration at Day 15
Serum erythropoietin (EPO) concentration measured in IU/L. Values represent the mean concentration at the end of randomized treatment.
Time frame: Day 15 (end of randomized treatment)
Estradiol Concentration at Day 15
Plasma estradiol measured in pmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
Time frame: Day 15 (end of randomized treatment)
Serum Ferritin Concentration at Day 15
Serum ferritin concentration measured in µg/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
Time frame: Day 15 (end of randomized treatment)
Plasma Testosterone Concentration at Day 15
Testosterone concentration measured in nmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
Time frame: Day 15 (end of randomized treatment)
Hematocrit at Day 15
Hematocrit, expressed as erythrocyte volume fraction (EVF), measured percent (%). Values represent the mean concentration at the end of randomized treatment.
Time frame: Day 15 (end of randomized treatment)
Hemoglobin Concentration at Day 15
Hemoglobin concentration measured in mmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
Time frame: Day 15 (end of randomized treatment)
Particpants recruited through notice boards as per protocol
| Milestone | Ketosis | Placebo |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
Venous plasma beta-hydroxybutyrate (BHB) concentration measured in mmol/L. The outcome represents the change from baseline (0 minutes) to the maximum observed BHB concentration during the acute ketosis exposure.
| mmol/l | BHB Ketone Monoester Drink | Placebo Drink Matched in Taste, Volume, and Viscosity |
|---|---|---|
| Change in Venous Plasma Beta-hydroxybutyrate (BHB) From Baseline to Peak During Acute Ketosis Exposure | 3.5 (3.3 to 3.8) | 0.04 (0.03 to 0.05) |
Serum erythropoietin (EPO) concentration measured in IU/L. Values represent the mean concentration at the end of randomized treatment.
| IU/L | Ketosis | Control |
|---|---|---|
| Serum Erythropoietin Concentration at Day 15 | 10.3 (7.7 to 12.8) | 8.2 (6.1 to 10.3) |
Testosterone concentration measured in nmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
| mmol/L | Ketosis | Control |
|---|---|---|
| Plasma Testosterone Concentration at Day 15 | 9.9 (6.8 to 13.0) | 12.0 (7.9 to 16.0) |
Plasma estradiol measured in pmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
| pmol/L | Ketosis | Control |
|---|---|---|
| Estradiol Concentration at Day 15 | 253 (-102 to 608) | 331 (-100 to 764) |
Serum ferritin concentration measured in µg/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
| µg/L | Ketosis | Control |
|---|---|---|
| Serum Ferritin Concentration at Day 15 | 72 (42 to 102) | 57 (32 to 83) |
Hematocrit, expressed as erythrocyte volume fraction (EVF), measured percent (%). Values represent the mean concentration at the end of randomized treatment.
| % of full blood | Ketosis | Control |
|---|---|---|
| Hematocrit at Day 15 | 41 (40 to 43) | 40 (39 to 42) |
Hemoglobin concentration measured in mmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
| mmol/L | Ketosis | Control |
|---|---|---|
| Hemoglobin Concentration at Day 15 | 8.6 (8.2 to 9.0) | 8.8 (8.4 to 9.2) |
Collected over Acute study visit and Baseline to Day 15. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketosis | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Control | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Acute Ketone Ester Exposure (Pre-Randomization) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(years) | Ketosis | Control | Total |
|---|---|---|---|
| Mean | 41.3 ± 9.1 | 44.2 ± 8.6 | 42 ± 8.7 |
| Sex: Female, Male(Participants) | Ketosis | Control | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 5 | 4 | 9 |
| Race and Ethnicity Not Collected(Participants) | Ketosis | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Erythropoietin(IU/L) | Ketosis | Control | Total |
|---|---|---|---|
| Mean | 9.0 ± 2.8 | 8.8 ± 4.8 | 8.9 ± 3.8 |
| Beta-hydroxybutyrate(mmol/L) | Ketosis | Control | Total |
|---|---|---|---|
| Mean | 0.04 ± 0.02 | 0.06 ± 0.04 | 0.05 ± 0.03 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2023 to primary completion in Jan 2024, 5 months.
Results were first posted in Mar 2026, 2 years 1 month after primary completion.
Of 99 non-industry interventional studies with no phase under Ketosis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 24. This study's 5 months is below that.
Counting every sponsor, half of 103 studies reached it within 14 months; a quarter within 7 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Central Jutland Regional Hospital