Effects of a low-carbohydrate ketogenic diet on reported pain, blood biomarkers and quality of life in patients with chronic pain: A pilot randomised clinical trial rationale, study design and protocol

Abstract Introduction A ketogenic diet has been shown to influence the nervous system and can potentially improve maladaptive changes occurring with chronic pain, specifically neuroinflammation and nervous system sensitisation. However, there is limited research on whether altering a standard western diet high in ultra-processed foods to a well-formulated ketogenic diet (WFKD) may reduce chronic pain. The aim of this clinical trial is to evaluate the effects of a WFKD on patients with chronic pain. Methods This is a 12-week pilot randomised clinical trial of adults with chronic musculoskeletal pain. All participants will commence with a 3-week run in whole-foods diet removing ultra-processed foods. At week 4 they will be randomised to either continue the whole food diet or start a WFKD (carbohydrate intake Conclusion This trial will evaluate the effects of a whole-food well formulated ketogenic diet on chronic pain perception. It attempts to address the commonalties between reported dietary approaches (diet quality and nutrient density) by using a comparator of equal food quality to allow the clinical evaluation of the ketogenic diet specifically on pain mechanisms. It will further the research on how a ketogenic diet may modulate physiology linked to chronic pain mechanisms such as metabolic dysregulation and inflammation.