Evaluation of a Ketogenic Diet for Improvement of Neurological Recovery in Individuals with Acute Spinal Cord Injury: study protocol for a randomized controlled trial

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Aynur DemirelCeren Yarar-Fisher

Abstract

Background: Therapies that significantly improve the neurological and functional recovery of individuals with spinal cord injury (SCI) are still urgently needed. The ketogenic diet (KD) has been shown to improve forelimb motor function in a rat model of SCI, likely by reducing inflammation and cell death in the spinal cord. Furthermore, our recent pilot study in patients with SCI showed that, compared with a standard hospital diet (SD), 5 weeks of KD, started during acute care, improved upper extremity motor function and reduced serum levels of a neuroinflammatory blood protein. The primary goals of our proposed study are to 1) show the safety and feasibility of administering a KD during acute care for SCI; 2) determine if consuming 5 weeks of a KD significantly improves motor and sensory function, functional independence, and glycemic control; and 3) quantify serum biomarkers that are linked to improvements in neurological recovery and functional independence via targeted proteomics.Methods/Design: In a single-masked, longitudinal, randomized parallel controlled study design, 60 participants with acute SCI will be randomly assigned to KD or SD in a 1:1 ratio. We intend to recruit 24 participants for each group with traumatic S...Continue Reading

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