Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Completing the intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-65 years
- •Diagnosed with posttraumatic stress disorder (PTSD)
- •Understand and speak Scandinavian language
排除标准
- •Body Mass Index < 18
- •Metabolic disorders contraindicating a ketogenic diet
- •Dysregulated Diabetes Mellitus
- •Medicated for elevated triglycerides
- •Pancreas, kidney or liver disorders
结局指标
主要结局
Completing the intervention
时间窗: 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.
Recruitment
时间窗: 25 weeks
How many patients can be included in the intervention group (percent out of all eligible patients during the inclusion period)
Adverse reactions related to the ketogenic treatment
时间窗: 4 weeks
The occurrence of adverse reactions (percent of days with adverse reactions during intervention)
Maintaining ketosis
时间窗: 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)
次要结局
- Assessment of severity of PTSD symptoms(4 weeks)
- Measure of Health-Related Quality of Life(4 weeks)
研究者
Jens Rikardt Andersen
Associate Professor
University of Copenhagen