Ketogenic Diet for Post-Traumatic Stress Disorder (PTSD)

NCT07415590 | Active Not Recruiting

• 1 other identifier: DE-2026-PTBS-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Post-Traumatic Stress Disorder, PTSD

Keywords

post-traumatic stress disorder; PTSD; ketosis; keto; ketogenic diet; pilot; feasibility; metabolic treatment; psychiatry; BHB; beta-hydroxybuterate; trauma; psychiatric condition; metabolic psychiatry

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Self-report feasibility

  Intervention: 12 weeks

Other Outcomes (1)

• Symptom Changes and Metabolic Markers

  Intervention: 12 weeks

Study Arms (1)

Ketogenic dietary intervention

OTHER

Other: Ketogenic diet

Interventions

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.

Ketogenic dietary intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bundeswehr University Munich: lead
• LMU Klinikum: collaborator

Study Sites (2)

Hochschulambulanz der Universität der Bundeswehr München

München, Bavaria, 80803, Germany

Location

LMU Klinikum (Klinik für Anästhesiologie)

München, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Ketosis; Wounds and Injuries

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robin Engelhardt, PhD

  Bundeswehr University Munich, Faculty of Human Sciences, Institute for Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)