Clinical trial NCT01025609: Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Official title: Dietary Patterns & There Relationship to Cardiovascular Disease Risk Factors In Individuals With Chronic Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
cardiovascular disease
dietary patterns
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2009-12-03
Enrollment: 134
Sex: ALL
Minimum age (years): 38
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 individuals with chronic spinal cord injuries

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.

Eligibility criteria: 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

Primary outcomes:
measure: Whole-grain intake
timeFrame: Day - 30
measure: Fruit and vegetable intake
timeFrame: Day - 30
measure: Dairy intake
timeFrame: Day - 30
Secondary outcomes:
measure: Waist circumference
timeFrame: Year 1
measure: Total cholesterol
timeFrame: Year 1
measure: HDL-C
timeFrame: Year 1
measure: LDL-C
timeFrame: Year 1
measure: Triglycerides
timeFrame: Year 1
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
Study officials:
affiliation: University of Minnesota
name: Pamela Shreiner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolinas Rehabilitation/Carolinas Medical Center
name: Jesse A. Lieberman, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.