Post-Traumatic Stress Disorder, PTSDNCT07415590
Ketogenic Diet for Post-Traumatic Stress Disorder (PTSD)
A study testing Ketogenic diet in people with Post-Traumatic Stress Disorder, PTSD, run by Bundeswehr University Munich at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, PTSD
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesGermany
- Study dates
- 12 Mar 2026to 7 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Hochschulambulanz der Universität der Bundeswehr München
München, Bavaria, 80803
LMU Klinikum (Klinik für Anästhesiologie)
München, Bavaria, 81377
About this study
Official title: Ketogenic Diet in the Treatment of PTSD in Germany: A Single-Arm Feasibility Study
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.
Read the detailed description
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.
- Conditions
- Post-Traumatic Stress Disorder, PTSD
- Being tested
- Ketogenic diet
- Keywords
- post-traumatic stress disorder, PTSD, ketosis, keto, ketogenic diet, pilot, feasibility, metabolic treatment, psychiatry, BHB, beta-hydroxybuterate, trauma, psychiatric condition, metabolic psychiatry
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic, Ketosis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic dietary intervention | Other | Not described Receives: Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intervention: 12 weeks
Secondary outcomes (1)
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.
Measured: Intervention: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Mar 2026
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder, PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bundeswehr University Munich
- Sponsor type
- University, hospital or other
- Collaborators
- LMU Klinikum
- Responsible party
- Principal investigator, Robin Engelhardt, Bundeswehr University Munich
- Investigators
- Robin Engelhardt, PhD, Principal investigator, Bundeswehr University Munich, Faculty of Human Sciences, Institute for Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415590
- Sponsor's protocol ID
- DE-2026-PTBS-01
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet in the Treatment of PTSD in Germany: A Single-Arm Feasibility Study
- ClinicalTrials.gov ID
- NCT07415590
- Acronym / sponsor ID
- DE-2026-PTBS-01
- Conditions
- Post-Traumatic Stress Disorder, PTSD
- Keywords
- post-traumatic stress disorder, PTSD, ketosis, keto, ketogenic diet, pilot, feasibility, metabolic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bundeswehr University MunichUniversity, hospital or other
- Collaborators
- LMU Klinikum
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic dietary intervention | Other | Other: Ketogenic diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietParticipants 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. | Other | Ketogenic dietary intervention |
Primary outcome
Process Feasibility
Time frame: Intervention: 12 weeks
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.
1 secondary outcome
Self-report feasibility
Time frame: Intervention: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Engelhardt, PhD principal investigator
Bundeswehr University Munich, Faculty of Human Sciences, Institute for Psychology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Post-Traumatic Stress Disorder, PTSD, run by Bundeswehr University Munich at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Process Feasibility (time frame: Intervention: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.