Utilizing a Low-Carbohydrate/High-Protein Diet to Improve Metabolic Health in Individuals with Spinal Cord Injury (DISH): study protocol for a randomized controlled trial [post]

2019 unpublished
Metabolic disorders (e.g., impaired glucose tolerance, insulin resistance, and type 2 diabetes) are more prevalent in people with spinal cord injury (SCI) vs. able-bodied individuals. Dietary modification is a more cost-effective treatment option than pharmacological therapies for reducing the risk of metabolic dysfunction. Lowering carbohydrate, increasing protein, and maintaining a proper dietary fat intake are expected to induce favorable adaptations in glucose control, body fat
more » ... and the composition of gut microbiome. However, dietary modification has not been rigorously investigated in people with SCI. The purpose of this study is to determine if an 8-week low-carbohydrate/high-protein (LC/HP) dietary intervention will show improvements in clinically important metrics of metabolic function, body composition, the composition of gut bacteria, and quality of life. Methods: We intend to recruit 100 participants with chronic traumatic SCI (3 years post-injury, C5-L2, AIS A-D, and 18-65 yr) and insulin resistance, impaired glucose tolerance or untreated type 2 diabetes and randomly assign them into an 8-week LC/HP dietary intervention group or a control group. The daily LC/HP dietary intervention includes ~30% total energy as protein (1.6 g/kg per day) with a carbohydrate-to-protein ratio <1.5 and fat intake set at ~30% of the total energy intake. The control group does not receive any dietary intervention and are continuing with their regular daily diets. Glucose tolerance, insulin sensitivity, β-cell function, body composition, gut microbiome composition, and quality of life measures are assessed at Week 1, before starting the LC/HP dietary intervention; and at Week 8, after completion of the LC/HP dietary intervention. Discussion: New and impactful information to be derived from this project will result in the development of a low-cost, simple, self-administered LC/HP dietary intervention for improving metabolic function in individuals with chronic SCI, improved understanding of the composition of gut bacteria in SCI, and how an LC/HP dietary intervention alters gut bacteria composition. In addition, this project will improve our understanding of the relationship between metabolic function and quality of life in individuals with long-standing SCI. Trial Registration: ClinicalTrials.gov, NCT03207841. Registered 5 June 2017,
doi:10.21203/rs.2.311/v1 fatcat:epyivbpvpncilnvisohbtw7ybe