PTSDNCT05415982
Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study
A study testing Ketogenic Diet in people with PTSD and Post Traumatic Stress Disorder, run by Jens Rikardt Andersen at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder
- What is being tested?
- Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- 20 Aug 2022to 8 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-65 years
- Diagnosed with posttraumatic stress disorder (PTSD)
- Understand and speak Scandinavian language
Who cannot join
- Body Mass Index < 18
- Metabolic disorders contraindicating a ketogenic diet
- Dysregulated Diabetes Mellitus
- Medicated for elevated triglycerides
- Pancreas, kidney or liver disorders
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Being tested
- Ketogenic Diet
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%,
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | Ketogenic Diet every day for 4 weeks Receives: Other: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
How many patients can be included in the intervention group (percent out of all eligible patients during the inclusion period)
Measured: 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.
Measured: 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)
Measured: 4 weeks
Adverse reactions related to the ketogenic treatment
The occurrence of adverse reactions (percent of days with adverse reactions during intervention)
Measured: 4 weeks
Secondary outcomes (2)
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)
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start20 Aug 2022
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Tobias Furuholmen-Jenssen, Student, Principal investigator, University of CopenhagenJens R Andersen, MD, MPA, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415982
- Sponsor's protocol ID
- Ketosis PTSD
- Status last verified
- Feb 2024
- First submitted
- 23 Mar 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39588043
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study
- ClinicalTrials.gov ID
- NCT05415982
- Acronym / sponsor ID
- Ketosis PTSD
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Other: Ketogenic DietKetogenic Diet every day for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18-65 years
- Diagnosed with posttraumatic stress disorder (PTSD)
- Understand and speak Scandinavian language
Key exclusion criteria (5 listed)
- Body Mass Index < 18
- Metabolic disorders contraindicating a ketogenic diet
- Dysregulated Diabetes Mellitus
- Medicated for elevated triglycerides
- Pancreas, kidney or liver disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic DietThe 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%, | Other | Ketogenic Diet |
Primary outcome
Recruitment
Time frame: 25 weeks
How many patients can be included in the intervention group (percent out of all eligible patients during the inclusion period)
Completing the intervention
Time frame: 4 weeks
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.
Maintaining ketosis
Time frame: 4 weeks
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)
Adverse reactions related to the ketogenic treatment
Time frame: 4 weeks
The occurrence of adverse reactions (percent of days with adverse reactions during intervention)
2 secondary outcomes
Assessment of severity of PTSD symptoms
Time frame: 4 weeks
Measure of Health-Related Quality of Life
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 39588043Edwards 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Furuholmen-Jenssen, Student principal investigator
University of Copenhagen
Jens R Andersen, MD, MPA study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet in people with PTSD and Post Traumatic Stress Disorder, run by Jens Rikardt Andersen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 25 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.