Low Carbohydrate/High Protein Diet to Improve Metabolic Health

Completed · Not applicable

Conditions studied: Spinal Cord, Metabolic Syndrome, Diabetes

In brief

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.

Key facts

Study ID

NCT03207841

Run by

Ohio State University

People needed

60

Starts

2017-11-01

Expected to finish

2022-08-29

Last updated by the study team

2023-03-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between the ages of 18 and 65 years
• diagnosis of traumatic SCI at the cervical, thoracic, or lumbar level (C5-L2) classified as American Spinal Cord Injury Association Classification (AIS) A, B, C, or D
• Impaired glucose tolerance or untreated type 2 diabetes
• at least 3 years post-injury.

You may not qualify if…

• Pregnant women.
• Neurological (other than SCI), vascular and/or cardiac problems that may limit function and interfere with testing procedures
• Patients with evidence of renal insufficiency and liver disease by history, physical examination, and laboratory tests
• Patients with underlying pulmonary diseases

Where it is running

• UAB — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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