Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study

Conditions
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PTSD, Post Traumatic Stress Disorder

Intervention / Treatment
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* Other: Ketogenic Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic Diet<br>Ketogenic Diet every day for 4 weeks | Other: Ketogenic Diet<br>* The intervention is a ketogenic diet based on high-fat ketogenic meals prepared by the study participants, complemented with ketogenic food products from Natural Ketosis and Vitaflo. Exogenous ketones are provided by Audacious Nutrition. The macronutrient composition of the ketogenic diet given approx.: Fat 87 E%, Carbohydrate 3 E%, Protein 10 E%,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | How many patients can be included in the intervention group (percent out of all eligible patients during the inclusion period) | 25 weeks | 
| Completing the intervention | How many patients complete the intervention of four weeks (percent out of all included patients) Completion is defined as adherence to the intervention daily for four weeks. | 4 weeks | 
| Maintaining ketosis | Could ketosis (mean b-BHB ≥ 0,5 mmol/L out of three daily measurements) be maintained for the duration of intervention (percent out of intervention days since ketosis first was obtained) | 4 weeks | 
| Adverse reactions related to the ketogenic treatment | The occurrence of adverse reactions (percent of days with adverse reactions during intervention) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of severity of PTSD symptoms | Change in PTSD Checklist for DSM-5 scale (PCL-5). 20 part item, 0-4 likert scale. Minimum value 0, maximum value 80 (Lower score is better) | 4 weeks | 
| Measure of Health-Related Quality of Life | Change in RAND 36-Item Health Survey 1.0 (RAND-36) - Scale is converted to numerical values for physical and mental health (each item is scored on a 0 to 100 range, so that the lowest and highest score are 0 and 100, respectively). Items in the same scale are averaged together to create 8 scale scores. A higher score defines a more faborable health state. | 4 weeks |