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NOT YET RECRUITING
NCT07415590
NA

Ketogenic Diet for Post-Traumatic Stress Disorder (PTSD)

Sponsor: Bundeswehr University Munich

View on ClinicalTrials.gov

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.

Official title: Ketogenic Diet in the Treatment of PTSD in Germany: A Single-Arm Feasibility Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-03-03

Completion Date

2026-07-13

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

OTHER

Ketogenic diet

Participants will undergo a medically supervised ketogenic dietary intervention, individually tailored to achieve and maintain low-level ketosis (β-hydroxybutyrate \[BHB\] concentrations typically ≥ 0.5 mmol/L) within two weeks. Depending on individual response and tolerability, participants may gradually adjust their dietary composition (e.g., by increasing the proportion of fat relative to protein and carbohydrates) to reach higher levels of ketosis (BHB typically ≥ 2.0 mmol/L) as an optional target. The dietary intervention will be guided and monitored by qualified dietitians under medical supervision.

Locations (2)

Hochschulambulanz der Universität der Bundeswehr München

München, Bavaria, Germany

LMU Klinikum (Klinik für Anästhesiologie)

München, Bavaria, Germany