NCT03207841

Low Carbohydrate/High Protein Diet to Improve Metabolic Health

Completed NA Last updated 27 March 2023

What this trial tests

NA trial testing LC/HP in Spinal Cord in 60 participants. Completed in 29 August 2022.

Timeline

1 November 2017

Primary endpoint
1 August 2022

29 August 2022

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	60
Start date	1 November 2017
Primary completion	1 August 2022
Estimated completion	29 August 2022
Sites	1 location across United States

Drugs / interventions tested

• LC/HP

Conditions studied

• Spinal Cord — all drugs for Spinal Cord →
• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Diabetes — all drugs for Diabetes →

Sponsor

Ohio State University

Who can join

Adults 18 to 60, any sex, with Spinal Cord or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Individuals with spinal cord injury (SCI) are living to ages when metabolic disorders are highly prevalent. The combination of impaired glucose tolerance and insulin resistance can disrupt lipid metabolism and increase the risk of cardiovascular disease and diabetes, and contribute to an accelerated aging process in the SCI population. Feasible interventions to improve metabolic function in the chronic SCI are in great demand. Compared to pharmacologic therapies, dietary modification is a more cost-effective treatment option for reducing the risk of metabolic dysfunction that, surprisingly, has not been rigorously investigated in people with SCI. Therefore, in the present study the investigators will investigate the efficacy of an 8-week, eucaloric (a meal plan designed specifically to provide the exact amount of calories needed to maintain a given body weight) LC-HP dietary intervention for improving metabolic function, body composition, gut bacteria composition and quality of life in individuals with SCI and impaired glucose tolerance or type 2 diabetes. The investigators also aim to determine the association between changes in the composition of gut bacteria and improvements in metabolic function and the association between improvements in metabolic function and improvements in quality of life.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of a low-carbohydrate/high-protein diet on metabolic health in individuals with chronic spinal cord injury: An exploratory analysis of results from a randomized controlled trial.
   Li J, Gower B, McLain A, Yarar-Fisher C. · · 2022 · cited 11× · PMID 36411989 · DOI 10.14814/phy2.15501
2. 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.
   Yarar-Fisher C, Li J, McLain A, Gower B, et al · · 2019 · cited 11× · PMID 31362773 · DOI 10.1186/s13063-019-3520-3