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

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Post Traumatic Stress Disorder
• Intervention / Treatment: Other: Ketogenic Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 1281
    • Søndre Oslo Distriktspsykiatriske Senter (DPS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketogenic Diet; Ketogenic Diet every day for 4 weeks	Other: Ketogenic Diet; 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%,

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Collaborators: Oslo University Hospital
• Investigators: Principal Investigator: Tobias Furuholmen-Jenssen, Student, University of Copenhagen; Study Director: Jens R Andersen, MD, MPA, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Ketosis PTSD

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