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Ketogenic Diet for Post-Traumatic Stress Disorder (PTSD)

NCT07415590 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-05-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • LMU Klinikum

    collaborator OTHER

  • Bundeswehr University Munich

    lead OTHER

Principal Investigators

  • Robin Engelhardt, PhD · Bundeswehr University Munich, Faculty of Human Sciences, Institute for Psychology

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2026-07-20
Completion
2026-07-20

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415590 on ClinicalTrials.gov