Low Carbohydrate/High Protein Diet to Improve Metabolic Health

NCT03207841 | Completed

• 1 other identifier: HHS-2016-ACL-NIDILRR-SI-0158
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord; Metabolic Syndrome; Diabetes

Keywords

SCI; High Protein; Low Carbohydrate; Metabolic Health; Microbiome

Outcome Measures

Primary Outcomes (5)

• Change in glucose tolerance

  Week1 and Week 8

• Change in insulin sensitivity

  Week 1 and Week 8

• Change in body mass index

  Week 1 and Week 8

• Change in gut bacterial composition

  Week 1 and Week 8

• Change in HDL, LDL, total cholesterol and triglycerides

  Week 1 and Week 8

Secondary Outcomes (1)

• Change in Spinal Cord Injury-Quality of Life (SCI-QOL) Score

  Week 1 and Week 8

Study Arms (2)

LC/HP group

EXPERIMENTAL

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.

Other: LC/HP

Control

NO INTERVENTION

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.

Interventions

LC/HP OTHER

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.

LC/HP group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

• Li J, Gower B, McLain A, Yarar-Fisher C. 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. Physiol Rep. 2022 Nov;10(22):e15501. doi: 10.14814/phy2.15501.

  PMID: 36411989 DERIVED

• Li J, Morrow C, McLain A, Womack ED, Yarar-Fisher C. Effects of a Low-Carbohydrate, High-Protein Diet on Gut Microbiome Composition in Insulin-Resistant Individuals With Chronic Spinal Cord Injury: Preliminary Results From a Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Jul;103(7):1269-1278. doi: 10.1016/j.apmr.2022.03.014. Epub 2022 Apr 10.

  PMID: 35417758 DERIVED

• Yarar-Fisher C, Li J, McLain A, Gower B, Oster R, Morrow C. 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. Trials. 2019 Jul 30;20(1):466. doi: 10.1186/s13063-019-3520-3.

  PMID: 31362773 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 5, 2017
• Study Start: November 1, 2017
• Primary Completion: August 1, 2022
• Study Completion: August 29, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)