The role of exogenous ketone bodies in maintaining immune homeostasis in healthy subjects

The role of exogenous ketone bodies in maintaining immune homeostasis in healthy subjects - ExoKeto

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034793

Enrollment

Registered

2024-10-28

Start date

2024-11-29

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study aims to determine the extent to which the intake of exogenous ketones, potentially combined with a low-carbohydrate diet, contributes to maintaining health and immune homeostasis in healthy subjects.

Interventions

Group 1: A cohort of adult volunteer subjects will undertake planned oral intake of exogenous ketone bodies—either ketone salts (KS

e.g., KETO//OS NAT, Prüvit or similar products) or ketone esters (KE

e.g., deltaG Ketone Performance or comparable products)—over a period of 3 or 12 weeks. Blood samples (50 ml whole blood each) will be collected before the study begins and after 3 and 12 weeks of exo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Healthy subjects - Written informed consent from the subject

Exclusion criteria

Exclusion criteria: - Women during pregnancy and lactation - Insulin-dependent diabetes mellitus - Personal relationship to the investigator (relatives, family members)

Design outcomes

Primary

Measure	Time frame
Change in peak ß-hydroxybutyrate concentration in capillary whole blood after 3 or 12 weeks of ketone body supplementation (point-of-care measurement)	—

Secondary

Measure	Time frame
- Analysis of immune homeostasis by examining mRNA expression profiles in immune cells - Analysis of inflammation-relevant mRNA and microRNA expression profiles using array analyses - Metabolome and proteome analyses from serum samples - Analyses of immune cell activation and function, as well as immune cell phenotyping using flow cytometry and Western blot - Mitochondrial analyses: quantification of mitochondrial membrane potential, ROS production, protein quantification of respiratory chain complexes via Western blot, oxygen consumption, and extracellular acidification - Analysis of clinical laboratory parameters (electrolytes, blood count, insulin, HbA1c, lipid metabolism parameters) - Bioelectrical impedance analysis - Microbiome analyses from stool samples - Analysis of amino acid metabolic pathways (especially tryptophan, phenylalanine) in urine - Analysis of bile acid metabolites in serum and urine - Assessment of subjective well-being	—

Measure

Time frame

- Analysis of immune homeostasis by examining mRNA expression profiles in immune cells - Analysis of inflammation-relevant mRNA and microRNA expression profiles using array analyses - Metabolome and proteome analyses from serum samples - Analyses of immune cell activation and function, as well as immune cell phenotyping using flow cytometry and Western blot - Mitochondrial analyses: quantification of mitochondrial membrane potential, ROS production, protein quantification of respiratory chain complexes via Western blot, oxygen consumption, and extracellular acidification - Analysis of clinical laboratory parameters (electrolytes, blood count, insulin, HbA1c, lipid metabolism parameters) - Bioelectrical impedance analysis - Microbiome analyses from stool samples - Analysis of amino acid metabolic pathways (especially tryptophan, phenylalanine) in urine - Analysis of bile acid metabolites in serum and urine - Assessment of subjective well-being

—

Countries

Germany

Contacts

Public ContactDavid Effinger

LMU Klinikum München. Klinik für Anästhesiologie

david.effinger@med.uni-muenchen.de+49 89 2180 76508

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026