Evaluation of a ketogenic diet for improvement of neurological recovery in individuals with acute spinal cord injury: study protocol for a randomized controlled trial

Trials, 2020 · DOI: https://doi.org/10.1186/s13063-020-04273-7 · Published: April 28, 2020

Spinal Cord Injury Neurology Nutrition & Dietetics

Simple Explanation

This study investigates whether a ketogenic diet (KD) can improve neurological and functional recovery in individuals with acute spinal cord injury (SCI). The KD has shown promise in reducing inflammation and cell death in the spinal cord in animal models. The primary goals are to assess the safety and feasibility of administering a KD during acute care, determine if it improves motor and sensory functions and quantify serum biomarkers linked to neurological recovery. Sixty participants with acute traumatic SCI will be enrolled in a single-masked, longitudinal, randomized, parallel-controlled study, comparing KD to a standard hospital diet (SD) over 5 weeks.

Study Duration

5 weeks

Participants

60 acutely traumatic spinal cord injured (cervical 5 to thoracic 12) participants

Evidence Level

Randomized Controlled Trial

Key Findings

1
The study aims to determine if a KD significantly improves motor and sensory function.
2
It will also evaluate if a KD improves functional independence and glycemic control in patients with acute SCI.
3
The research seeks to quantify serum biomarkers linked to improvements in neurological recovery and functional independence via targeted proteomics.

Research Summary

This study protocol outlines a randomized controlled trial to evaluate the impact of a ketogenic diet (KD) on neurological recovery in individuals with acute spinal cord injury (SCI). The trial aims to assess the safety, feasibility, and potential benefits of a 5-week KD intervention compared to a standard hospital diet (SD) on motor and sensory functions, functional independence, and glycemic control. The study will also investigate serum biomarkers linked to neurological recovery through targeted proteomics, seeking to identify molecular mechanisms underlying any observed improvements.

Practical Implications

Low-Cost Intervention

A more neuroprotective diet during acute care of SCI can be implemented anywhere in the world at low cost.

Improved Quality of Life

Better functional recovery will lead to a better quality of life and long-term health outcomes in individuals with SCI.

Broad Application

If successful, it has the potential to improve neurological outcomes for individuals with various traumatic injuries.

Study Limitations

1
The study is limited by the difficulties of inadequate masking of the ketogenic diet.
2
Exclusion criteria include several pre-existing conditions that may limit the generalizability of the findings.
3
The study focuses on adults with acute SCI, excluding children and limiting the applicability to other age groups.

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