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

NCT06053138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-28

Study results available
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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

Interventions

DIETARY_SUPPLEMENT

Ketone monoester

Supraphysiological ketosis induced by ingestion of a ketone monoester dietary supplement administered intermittently during the randomized two-week intervention period.

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Central Jutland Regional Hospital

    lead OTHER

Principal Investigators

  • Henrik H Thomsen, Ph.D. · Department of Internal Medicine, Viborg Regional Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-24
Primary Completion
2024-01-30
Completion
2024-08-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053138 on ClinicalTrials.gov