Ketogenic Diet for Post-Traumatic Stress Disorder (PTSD)

May 9, 2026 updated by: Robin Engelhardt, Bundeswehr University Munich

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • München, Bavaria, Germany, 80803
        • Hochschulambulanz der Universität der Bundeswehr München
      • München, Bavaria, Germany, 81377
        • LMU Klinikum (Klinik für Anästhesiologie)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ketogenic dietary intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intervention: 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report feasibility
Time Frame: Intervention: 12 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Changes and Metabolic Markers
Time Frame: Intervention: 12 weeks
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.
Intervention: 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bundeswehr University Munich

Collaborators

LMU Klinikum

Investigators

  • Principal Investigator: Robin Engelhardt, PhD, Bundeswehr University Munich, Faculty of Human Sciences, Institute for Psychology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE-2026-PTBS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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