Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury (SCIDS)

Dietary Patterns & There Relationship to Cardiovascular Disease Risk Factors In Individuals With Chronic Spinal Cord Injury

This study will look at dietary patterns in individuals with chronic spinal cord injuries and the relationship between these dietary patterns and cardiovascular disease risk factors. The study is a supplement to the Coronary Artery Risk Development in Young Adults (CARDIA) study. The dietary history from CARDIA will be used. The investigators' primary hypothesis is the following: Greater whole-grain and dietary fiber intake will be favorably associated with adiposity (BMI and WC) and metabolic CVD risk factors (fasting glucose, fasting insulin, HOMA-IR, diabetes, hsCRP, TC, HDL-C, triglycerides, TC/HDL-C ratio, non-HDL-C, and systolic and diastolic blood-pressure) among a sample of individuals with SCI aged 38-50 who have been injured >1 year.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury

Detailed Description

This study is a cross-sectional study. It will look at dietary patterns in individuals with chronic spinal cord injuries and the relationship between these dietary patterns and cardiovascular disease risk factors. The study is a supplement to the Coronary Artery Risk Development in Young Adults (CARDIA) study. The dietary history from CARDIA will be used. The investigators' primary hypothesis is the following: Greater whole-grain and dietary fiber intake will be favorably associated with adiposity (BMI and WC) and metabolic CVD risk factors (fasting glucose, fasting insulin, HOMA-IR, diabetes, hsCRP, TC, HDL-C, triglycerides, TC/HDL-C ratio, non-HDL-C, and systolic and diastolic blood-pressure) among a sample of individuals with SCI aged 38-50 who have been injured >1 year.

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 individuals with chronic spinal cord injuries

Description

Inclusion Criteria

• Male or female, black or white with SCI due to a nonvascular insult that caused an acute spinal cord injury (i.e. traumatic injury, transverse myelitis without a diagnosis of multiple sclerosis, surgical complication, or benign neoplasm) at least 1 year prior to enrollment including ASIA A,B,C
• Age at time of enrollment: > 38 years and <55 years (i.e., on or after 38th birthday and before 55th birthday)
• Voluntary, informed consent of participant
• Participant willing to comply with the testing protocols and questionnaires
• Communication and comprehension sufficient for compliance with all testing procedures and measures Exclusion Criteria
• SCI of a vascular or malignant etiology
• Pregnancy, end-stage renal disease, treatment for cancer except for non-melanoma skin cancer in the past five years
• Injury < 1 years prior to enrollment
• ASIA D
• Chronic, nontobacco substance-abuse

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-grain intake	Average number of whole grain servings per day	Day - 30
Fruit and vegetable intake	Average number of fruit and vegetable servings per day	Day - 30
Dairy intake	Average number of dairy servings per day	Day - 30

Secondary Outcome Measures

Outcome Measure	Time Frame
Waist circumference	Year 1
Total cholesterol	Year 1
HDL-C	Year 1
LDL-C	Year 1
Triglycerides	Year 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: University of Minnesota
• Investigators: Principal Investigator: Pamela Shreiner, PhD, University of Minnesota; Study Director: Jesse A. Lieberman, M.D., Carolinas Rehabilitation/Carolinas Medical Center

Publications and helpful links

General Publications

• Lieberman J, Goff D Jr, Hammond F, Schreiner P, Norton HJ, Dulin M, Zhou X, Steffen L. Dietary intake and adherence to the 2010 Dietary Guidelines for Americans among individuals with chronic spinal cord injury: a pilot study. J Spinal Cord Med. 2014 Nov;37(6):751-7. doi: 10.1179/2045772313Y.0000000180. Epub 2014 Jan 3.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cardiovascular disease; spinal cord injury; dietary patterns
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 04-09-17E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No