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Ketogenic Diet for Post-Traumatic Stress Disorder (PTSD)

CompletedNA

Sponsor: Bundeswehr University Munich

Conditions: Post-Traumatic Stress Disorder, PTSD

Interventions: Ketogenic diet

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Mental capacity to provide informed consent
* Provides written confirmation of informed consent
* Adults (18-65 years)
* Verified PTSD diagnosis according to DSM 5-TR or ICD-11
* Currently living in Germany
* High treatment motivation (score \> 7/10)
* Consent to information sharing within study staff (release from medical confidentiality)
* No medical or psychiatric contraindication

Exclusion Criteria:

* Pregnant or breastfeeding
* Active alcohol or drug misuse
* BMI \< 18.5
* Currently medicated with glucocorticoids, lithium, anticonvulsants, hypertension medication, glucose-lowering medications, or SGLT-2 inhibitor medications
* Diagnosed with type 1 or type 2 diabetes
* Diagnosed with severely impaired kidney function
* Diagnosed with ESLD (End Stage Liver Disease) or ESRD (End Stage Renal Disease)
* Follows a vegan diet
* History of eating disorders
* Acute or chronic suicidality
* Acute or chronic self-injury behavior
* Acute positive psychotic/manic symptomatology
* Already following a ketogenic diet within the past 6 weeks
* Any change to psychiatric medication regimen in past 6 weeks
* Severe hypercholesterolemia (may represent genetic metabolic disorder)
* Porphyria, heart failure, pancreatitis
* Institutionally dependent individuals

Locations (2)

München, Bavaria, Germany
München, Bavaria, Germany