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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05415982
• Other study ID #: Ketosis PTSD
• Status: Completed
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: February 8, 2023

Study information

• Verified date: February 2024
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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%,

Locations

Country	Name	City	State
Norway	Søndre Oslo Distriktspsykiatriske Senter (DPS)	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Jens Rikardt Andersen	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	How many patients can be included in the intervention group (percent out of all eligible patients during the inclusion period)	25 weeks
Primary	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
Primary	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
Primary	Adverse reactions related to the ketogenic treatment	The occurrence of adverse reactions (percent of days with adverse reactions during intervention)	4 weeks
Secondary	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
Secondary	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