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

Spinal Cord Injury Clinical Trial

— SCIDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025609
• Other study ID #: 04-09-17E
• Status: Completed
• Start date: September 2009
• Est. completion date: July 2012

Study information

• Verified date: July 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 38 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Carolinas Rehabilitation	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole-grain intake	Average number of whole grain servings per day	Day - 30
Primary	Fruit and vegetable intake	Average number of fruit and vegetable servings per day	Day - 30
Primary	Dairy intake	Average number of dairy servings per day	Day - 30
Secondary	Waist circumference		Year 1
Secondary	Total cholesterol		Year 1
Secondary	HDL-C		Year 1
Secondary	LDL-C		Year 1
Secondary	Triglycerides		Year 1