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| Name | Class |
|---|---|
| LMU Klinikum | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic dietary intervention | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intervention: 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intervention: 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Engelhardt, PhD | Bundeswehr University Munich, Faculty of Human Sciences, Institute for Psychology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hochschulambulanz der Universität der Bundeswehr München | München | Bavaria | 80803 | Germany | ||
| LMU Klinikum (Klinik für Anästhesiologie) |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D007662 | Ketosis |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D000138 | Acidosis |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
| Intervention: 12 weeks |
| München |
| Bavaria |
| 81377 |
| Germany |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |