An interventional study of Ketogenic diet in Post-Traumatic Stress Disorder, PTSD, sponsored by Bundeswehr University Munich. Completed at 2 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Bundeswehr University Munich · Not applicable, Interventional, and Other
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.
Post-traumatic stress disorder (PTSD) is characterized by intrusive re-experiencing of traumatic events and clinically relevant impairments in mood and functioning. In Germany, PTSD affects a meaningful proportion of the general population and is particularly prevalent in refugee populations. Although trauma-focused psychotherapies are considered first-line treatments, many patients face access barriers and high dropout rates, and currently available pharmacological approaches show limited remission rates.
Emerging evidence suggests that PTSD is associated with trauma-related metabolic dysregulation, including inflammatory processes and mitochondrial impairments. Ketogenic therapy - most commonly implemented via a ketogenic diet (KD) - is a metabolic intervention with documented neuroprotective and anti-inflammatory properties and early evidence of benefit across several psychiatric conditions. Given the overlap between proposed KD mechanisms and PTSD pathophysiology, evaluating KD as a potential intervention for PTSD is a promising and novel research direction. However, prospective feasibility data in German PTSD cohorts are currently lacking, which justifies a human pilot trial under real-world clinical conditions.
This study is a 12-week, single-arm, open-label feasibility trial in six adults with verified PTSD living in Germany. The primary objective is to evaluate feasibility with respect to recruitment, adherence to ketosis, completion of study assessments, and retention. Secondary objectives assess participant-reported feasibility. Exploratory objectives include changes in PTSD symptoms and general mental health, associations between daily capillary β-hydroxybutyrate (BHB) levels and daily symptom severity, identification of barriers and facilitators relevant to future trials, and descriptive changes in metabolic, inflammatory, and mitochondrial markers. Participants will receive a medically supervised, individually tailored KD with structured dietary support. Adherence and symptom trajectories will be monitored via daily BHB measurements and brief daily self-reports.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's enrollment of 6 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Bundeswehr University Munich is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Process Feasibility
The primary endpoints assess feasibility based on recruitment success, adherence to the ketogenic intervention, completion of study assessments, and participant retention over the 12-week intervention period.
Time frame: Intervention: 12 weeks
Self-report feasibility
Participant self-reported feasibility will be assessed at the end of the intervention using brief quantitative ratings and open-ended questions, with qualitative feedback used to contextualize the quantitative results.
Time frame: Intervention: 12 weeks
Symptom Changes and Metabolic Markers
Exploratory outcomes include psychological outcomes such as changes in PTSD symptom severity, mental health, and functioning, as well as daily PTSD symptom monitoring and beta-hydroxybuterate measurements to examine temporal relationships between ketone levels and symptom fluctuations. In addition, physiological and metabolic parameters - including inflammatory and mitochondrial markers as well as immunometabolic analyses - will be collected to explore pathophysiological mechanisms.
Time frame: Intervention: 12 weeks
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Bundeswehr University Munich