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

NCT06053138 | Completed Results

• 1 other identifier: 1-16-02-279-23
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ketosis

Keywords

ketosis; ketone monoester; erythropoitin; sex hormones

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Day 15 (end of randomized treatment)

Secondary Outcomes (1)

• Serum Ferritin Concentration at Day 15

  Day 15 (end of randomized treatment)

Other Outcomes (3)

• Plasma Testosterone Concentration at Day 15

  Day 15 (end of randomized treatment)

• Hematocrit at Day 15

  Day 15 (end of randomized treatment)

• Hemoglobin Concentration at Day 15

  Day 15 (end of randomized treatment)

Study Arms (2)

Ketosis

EXPERIMENTAL

Ketosis (the condition being investigated) is obtained by ingestion of a ketone monoester

Dietary Supplement: Ketone monoester

Control

PLACEBO COMPARATOR

The control arm is a drink matched in taste, volume, appearence, and viscosity to that of the active/experimental arm

Dietary Supplement: Placebo

Interventions

Ketone monoester DIETARY_SUPPLEMENT

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

Ketosis

Placebo DIETARY_SUPPLEMENT

The placebo vehicle is matched to the ketosis intervention in the experimental arm with regards to taste, volume, viscosity, appearence, and packaging

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (1)

Department of Internal Medicine, Viborg Regional Hospital

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The study was adequately powered for erythropoietin outcomes but had limited power for sex-specific analyses and downstream erythropoietic endpoints due to sample size and duration.

Results Point of Contact

• Title: Henrik Holm Thomsen
• Organization: Regional Hospital Central Jutland

henths@rm.dk

50721835

Study Officials

• Henrik H Thomsen, Ph.D.

  Department of Internal Medicine, Viborg Regional Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants are blinded to the drink (intervention) being either ketosis (obtained by ingestion of a ketone monoester drink) or placebo (a taste and volume matched drink). Drinks are provided in similar neutral unlabelled bottles
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Participants were randomized in a parallel design to receive either intermittent BHB ketone ester supplementation or matched placebo.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 25, 2023
• Study Start: August 24, 2023
• Primary Completion: January 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 28, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)