Clinical trial NCT05415982: Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study
Official title: Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Post Traumatic Stress Disorder
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2022-06-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Many patients suffering from posttraumatic stress disorder (PTSD) are resistant to established treatment consisting of psychotherapy. Patients often go years with this debilitating disorder without experiencing sufficient improvement. Approximately 1/3 of patients will drop out of treatment because of psychological burden and overactivation. A novel ketogenic diet treatment could amend established treatment, and potentially upregulate the threshold for exciting neurons in dysfunctional brain regions, mediated through various mechanisms. This may reduce PTSD symptoms, and thus enabling patients to respond to psychological treatment without getting overactivated and unable to process trauma. The purpose of this study is to investigate whether it is possible to carry out a ketogenic diet therapy for patients with PTSD for four weeks.

Detailed description: The study aims to include 10 PTSD patients. If a participant drops out of the study, or if the study is otherwise terminated for a participant, another patient will be recruited until 10 have completed the study. The primary objectives of this feasibility study are to investigate if it is possbile to carry out a ketogenic diet therapy for patients with PTSD for 4 weeks, and systematically gain insight in all challenges relating to these objectives. The participants will follow a ketogenic diet for 4 weeks, and they are asked to self report daily on results from finger pricking blood measurements (glucose and betahydroxybutyrate (BHB)) to establish they are in a ketogenic state and are compliant to diet. Participants will also report food intake and side effects daily to be evaluated by the principal investigator. Participants are further asked to specify and elaborate on which adverse effects or other reasons as to why it is challenging to follow the study diet and/or procedures. The study lacks in power to statistically evaluate if ketosis has any effect on PTSD symptoms, however this secondary objective will be preliminary evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients 18-65 years
* Diagnosed with posttraumatic stress disorder (PTSD)
* Understand and speak Scandinavian language

Exclusion Criteria:

* Body Mass Index \< 18
* Metabolic disorders contraindicating a ketogenic diet
* Dysregulated Diabetes Mellitus
* Medicated for elevated triglycerides
* Pancreas, kidney or liver disorders

Primary outcomes:
measure: Recruitment
timeFrame: 25 weeks
measure: Completing the intervention
timeFrame: 4 weeks
measure: Maintaining ketosis
timeFrame: 4 weeks
measure: Adverse reactions related to the ketogenic treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Assessment of severity of PTSD symptoms
timeFrame: 4 weeks
measure: Measure of Health-Related Quality of Life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Søndre Oslo Distriktspsykiatriske Senter (DPS)
Study officials:
affiliation: University of Copenhagen
name: Tobias Furuholmen-Jenssen, Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Jens R Andersen, MD, MPA
role: STUDY_DIRECTOR
References: