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Spinal Cord InjurySCIDSNCT01025609

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

An observational study of Spinal Cord Injury, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 38 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injury
How many people
134 participants
Where
1 siteUnited States
Study dates
Sep 2009to Jul 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 38 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: 100 individuals with chronic spinal cord injuries

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Carolinas Rehabilitation

    Charlotte, North Carolina, 28203

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
spinal cord injury, cardiovascular disease, dietary patterns
Medical subject headings
Spinal Cord Injuries, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whole-grain intake

    Average number of whole grain servings per day

    Measured: Day - 30

  2. Fruit and vegetable intake

    Average number of fruit and vegetable servings per day

    Measured: Day - 30

  3. Dairy intake

    Average number of dairy servings per day

    Measured: Day - 30

Secondary outcomes (5)

  1. Waist circumference

    Measured: Year 1

  2. Total cholesterol

    Measured: Year 1

  3. HDL-C

    Measured: Year 1

  4. LDL-C

    Measured: Year 1

  5. Triglycerides

    Measured: Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01025609
Sponsor's protocol ID
04-09-17E
Acronym
SCIDS
Status last verified
Jul 2021
First submitted
2 Dec 2009
Last updated
29 Jun 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 24621049

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injury, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whole-grain intake (time frame: Day - 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01025609, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.

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