Clinical Trial

Ketogenic Diet for Post-Traumatic Stress Disorder (PTSD)

Completed
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Summary
This project is a prospective, single-arm, open-label feasibility study testing whether a 12-week medically supervised ketogenic diet (KD) can be implemented in adults with PTSD in Germany (N=6). The primary aim is feasibility: recruitment (N=6 within a predefined timeframe), adherence to ketosis measured by daily capillary β-hydroxybutyrate (BHB), completion of study assessments (including daily EMA symptom/BHB reporting), and retention through the post-intervention visit. Secondary outcomes include participant self-reported feasibility at week 12. Exploratory outcomes include descriptive changes in PTSD symptoms/mental health and metabolic/inflammatory/mitochondrial biomarkers as well as associations between biomarkers and PTSD symptoms. The study is not powered for efficacy; results will inform the design of a larger clinical trial.
Protocol Amendment History 2 changes
critical Trial completed 2026-08-14
critical Trial status changed: Not Yet Recruiting → Active, Not Recruiting 2026-05-14
Trial Details
NCT Number NCT07415590
Lead Sponsor Bundeswehr University Munich
Collaborators: LMU Klinikum
Conditions Post-Traumatic Stress Disorder, PTSD
Enrollment 6 participants
Start Date 2026-03-12
Primary Completion 2026-08-07 (estimated)
Study Completion 2026-08-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-13