NCT05415982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

March 23, 2022

Last Update Submit

February 4, 2024

Conditions

PTSDPost Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Assessment of severity of PTSD symptoms

    4 weeks

  • Measure of Health-Related Quality of Life

    4 weeks

Study Arms (1)

Ketogenic Diet

EXPERIMENTAL

Ketogenic Diet every day for 4 weeks

Other: Ketogenic Diet

Interventions

Ketogenic DietOTHER

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%,

Ketogenic Diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Søndre Oslo Distriktspsykiatriske Senter (DPS)

Oslo, 1281, Norway

Location

Related Publications (1)

  • Edwards MGP, Furuholmen-Jenssen T, Soegaard EGI, Thapa SB, Andersen JR. Exploring diet-induced ketosis with exogenous ketone supplementation as a potential intervention in post-traumatic stress disorder: a feasibility study. Front Nutr. 2024 Oct 31;11:1406366. doi: 10.3389/fnut.2024.1406366. eCollection 2024.

    PMID: 39588043DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Tobias Furuholmen-Jenssen, Student

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Jens R Andersen, MD, MPA

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 23, 2022

First Posted

June 13, 2022

Study Start

August 20, 2022

Primary Completion

February 8, 2023

Study Completion

February 8, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)