Ketogenic Diet for Post-Traumatic Stress Disorder (PTSD)
Germany6 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.