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Completed

NCT Number: NCT01025609

Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) 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.

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Key information

Age range

38 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Whole-grain intake

    Time frame: Day - 30

    Average number of whole grain servings per day

  2. Fruit and vegetable intake

    Time frame: Day - 30

    Average number of fruit and vegetable servings per day

  3. Dairy intake

    Time frame: Day - 30

    Average number of dairy servings per day

Secondary outcomes

  1. Waist circumference

    Time frame: Year 1

  2. Total cholesterol

    Time frame: Year 1

  3. HDL-C

    Time frame: Year 1

  4. LDL-C

    Time frame: Year 1

  5. Triglycerides

    Time frame: Year 1

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • University of Minnesota

Registry information

Official study title

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

Acronym: SCIDS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2009
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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