N/A N=16 Randomized Triple-blind Basic Science

Assessment of BHB Concentration Agreement Among Sampling Locations and the Impact of Ketosis on EPO, and More

Ketosis

Bottom Line

View on ClinicalTrials.gov: NCT06053138 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Change in Venous Plasma Beta-hydroxybutyrate (BHB) From Baseline to Peak During Acute Ketosis Exposure — 3.5; 0.04 mmol/l

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ketone monoester (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Central Jutland Regional Hospital
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Venous Plasma Beta-hydroxybutyrate (BHB) From Baseline to Peak During Acute Ketosis Exposure	3.5; 0.04	—
PRIMARY Serum Erythropoietin Concentration at Day 15	10.3; 8.2	—
PRIMARY Estradiol Concentration at Day 15	253; 331	—
SECONDARY Serum Ferritin Concentration at Day 15	72; 57	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Age 18-60 years
BMI 19-30 kg/m2
Expected ease of catheter insertion
Considered of sound health
Oral and written informed consent

Exclusion Criteria

Inability to fully understand the consent including consent forms
Inability to cooperate to the study
electrolyte disorders
acute or chronic kidney disease or ompromised renal function including excess risk
servere hypertension
autoimmune disease
liver or bile disease
diabetes mellitus
reactive hypoglycemia or similar disorders
treatment with drugs, and dietary supplements with inference on key metabolic or hormonal markers, e.g. insulin, glucagon, DDP-IV inhibitors, GLP-1 RA, sulfunylurea
use of illegal or otherwise use of medicinal products without prescription
anemia or other know disease of the hematopoietic system
previous bariatric surgery
previous myocardial infarction or uncontrolled myocardial ischemia
recent intended/unintended weight loss
allergies to catheters or adhesives

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06053138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.