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

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT01025609
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2021-07
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dairy intake	Day - 30	Average number of dairy servings per day
Whole-grain intake	Day - 30	Average number of whole grain servings per day
Fruit and vegetable intake	Day - 30	Average number of fruit and vegetable servings per day

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	Year 1
LDL-C	Year 1
Waist circumference	Year 1
Triglycerides	Year 1
HDL-C	Year 1

Trial Locations

Locations (1)

Carolinas Rehabilitation; 🇺🇸 Charlotte, North Carolina, United States