Utilizing a Low-Carbohydrate/High-Protein Diet to Improve Metabolic Health in Individuals With Spinal Cord Injury

Trial Information
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable

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.

Am I eligible for this trial?
Participation Requirements
Minimum Age:
Maximum Age:
Healthy Volunteers:

• 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.

Where is this trial taking place?
United States
When is this trial taking place?
Start Date: November 1, 2017
Estimated Completion Date: October 1, 2022
How many participants will be in this trial?
Target number of participants: 100
What treatment is being studied in this trial?
Experimental: LC/HP group
Intervention group will receive 8 weeks of LC/HP diet. The daily LC-HP dietary intervention will include ~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. Dietary fat sources will focus on monounsaturated and polyunsaturated fats, e.g., plant oils and nuts; dietary carbohydrate sources will emphasize whole grains, fruits, vegetables, and legumes; and dietary protein sources will include lean meats, fish, chicken, eggs, and nonfat dairy foods, e.g., fat-free milk and low-fat cheese, consistent with American Diabetes Association and Institute of Medicine guidelines. All LC-HP meals will be provided by UAB Center for Clinical and Translational Sciences (CCTS) Bionutrition Unit and delivered to participants' homes 3 times/week (a sample menu is included in Appendix J). Every delivery will include breakfast, lunch, dinner, and snacks for 2 to 3 days.
No Intervention: Control
Control group will not receive the experimental diet and will continue with their usual diets. Participants will complete three 24-hour food recalls (on 2 week days and one day in the weekend) three times (at weeks 1, 4 and 8) during the course of the study to gather dietary information including dietary intake and/or particular aspects of the diet. Participants will be asked to recall foods and beverages they consumed in the 24 hours prior to the interview. Three 24-hour food recalls appear optimal for estimating energy intake.

This content was sourced from clinicaltrials.gov