Ketogenic Dietary Intervention as a Potential Adjunctive Therapy for Inflammatory Rheumatic Diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040345

Enrollment

Registered

2026-07-01

Start date

2026-07-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Rheumatoid Arthritis and Psoriatic Arthritis

Interventions

Group 1: 14-day ketogenic dietary intervention in addition to unchanged standard therapy in patients with rheumatoid arthritis or psoriatic arthritis who have been receiving stable, unchanged pharmaco

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of rheumatoid arthritis or psoriatic arthritis Stable and unchanged pharmacological therapy for at least six weeks Written informed consent provided by the participant

Exclusion criteria

Exclusion criteria: - Active malignant disease - Current ketogenic or carbohydrate-restricted diet - Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
- Change in the frequency of pathogenic Th17.1 cells, determined by flow cytometry. - Change in mitochondrial reserve capacity, determined by Seahorse analysis. - Change in mitochondrial reactive oxygen species (ROS), determined by MitoSOX staining and flow cytometry. - Change in the expression of phosphorylated mTOR (Ser235/236), determined by flow cytometry and Western blot analysis. All primary endpoints will be assessed before initiation of the ketogenic diet (T0) and after completion of the 14-day ketogenic dietary intervention (T1) and analyzed using an intra-individual comparison.	—

Measure

Time frame

- Change in the frequency of pathogenic Th17.1 cells, determined by flow cytometry. - Change in mitochondrial reserve capacity, determined by Seahorse analysis. - Change in mitochondrial reactive oxygen species (ROS), determined by MitoSOX staining and flow cytometry. - Change in the expression of phosphorylated mTOR (Ser235/236), determined by flow cytometry and Western blot analysis. All primary endpoints will be assessed before initiation of the ketogenic diet (T0) and after completion of the 14-day ketogenic dietary intervention (T1) and analyzed using an intra-individual comparison.

—

Secondary

Measure	Time frame
- Immunophenotyping of Th17 and Treg cells, including their respective subpopulations, determined by flow cytometry. - Change in Treg suppressive function, determined by Treg suppression assay. - Change in cytokine secretion, determined by multiplex ELISA. - Change in mitochondrial oxidative phosphorylation (OXPHOS) and cellular glycolysis, determined by Seahorse analysis. - Change in the expression of mitochondrial respiratory chain complexes I–V, determined by Western blot analysis. - Change in immune cell activation and immune cell function, determined by flow cytometry and Western blot analysis. - Change in the expression of immunometabolic signaling pathways (HIF1a, AMPK, mTOR), determined by qRT-PCR, flow cytometry, and Western blot analysis. - Change in the phosphorylation status of AMPK and mTOR and the degradation status of HIF1a, determined by flow cytometry and Western blot analysis. - Change in gene expression of Treg and Th17 cells, determined by next-generation sequencing (NGS). - Identification of differentially regulated gene clusters relevant to immune function and metabolism, determined by NGS and validated by qRT-PCR, Western blot analysis, and flow cytometry. - Change in the serum metabolome, determined by time-of-flight (TOF) mass spectrometry. - Change in the serum proteome, determined by proteomic analysis. - Change in disease activity, determined by the Disease Activity Score 28 (DAS28). - Change in general health status, determined by the Short Form Health Survey 36 (SF-36). - Change in health-related quality of life, determined by the World Health Organization Quality of Life Assessment 100 (WHOQOL-100). All secondary endpoints will be assessed before initiation of the ketogenic diet (T0) and after completion of the 14-day ketogenic dietary intervention (T1) and analyzed using an intra-individual comparison.	—

Measure

Time frame

- Immunophenotyping of Th17 and Treg cells, including their respective subpopulations, determined by flow cytometry. - Change in Treg suppressive function, determined by Treg suppression assay. - Change in cytokine secretion, determined by multiplex ELISA. - Change in mitochondrial oxidative phosphorylation (OXPHOS) and cellular glycolysis, determined by Seahorse analysis. - Change in the expression of mitochondrial respiratory chain complexes I–V, determined by Western blot analysis. - Change in immune cell activation and immune cell function, determined by flow cytometry and Western blot analysis. - Change in the expression of immunometabolic signaling pathways (HIF1a, AMPK, mTOR), determined by qRT-PCR, flow cytometry, and Western blot analysis. - Change in the phosphorylation status of AMPK and mTOR and the degradation status of HIF1a, determined by flow cytometry and Western blot analysis. - Change in gene expression of Treg and Th17 cells, determined by next-generation sequencing (NGS). - Identification of differentially regulated gene clusters relevant to immune function and metabolism, determined by NGS and validated by qRT-PCR, Western blot analysis, and flow cytometry. - Change in the serum metabolome, determined by time-of-flight (TOF) mass spectrometry. - Change in the serum proteome, determined by proteomic analysis. - Change in disease activity, determined by the Disease Activity Score 28 (DAS28). - Change in general health status, determined by the Short Form Health Survey 36 (SF-36). - Change in health-related quality of life, determined by the World Health Organization Quality of Life Assessment 100 (WHOQOL-100). All secondary endpoints will be assessed before initiation of the ketogenic diet (T0) and after completion of the 14-day ketogenic dietary intervention (T1) and analyzed using an intra-individual comparison.

—

Countries

Germany

Contacts

Public ContactSimone Kreth

LMU Klinikum München Klinik für Anästhesiologie

simone.kreth@med.uni-muenchen.de+49 89 2180 76508

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026