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Clinical Trials/NCT03518892
NCT03518892CompletedNot Applicable

Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury

Milton S. Hershey Medical Center1 site in 1 country16 target enrollmentStarted: March 19, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Percentage of Body fat

Study Overview

Brief Summary

Assess the relationship between body composition, metabolism, and dietary needs in people with spinal cord injury compared to their healthy controls that are age and sex matched.

Detailed Description

This study will quantify body composition and resting metabolic rate and then compare these parameters to results from a nutritional analysis. Participants will have two study visits that include physical exam, blood draws, resting metabolic rate, Dual Energy X-ray Absorptiometry (DXA) scan, and dietary assessments.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • C4-L2 motor complete (AIS A & B) Spinal Cord injury for duration greater than 12 months.
  • <5% change in body in body weight over the past 12 months
  • Fluent in written and spoken English

Exclusion Criteria

  • <22% body fat
  • Coronary artery disease
  • Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose>126 or HgbA1c>7.0)
  • Hypothyroidism, and/or renal disease
  • Decisional impairment

Outcomes

Primary Outcomes

Percentage of Body fat

Time Frame: Week 2

Dietary Assessment Using Self-Reported Diary Questionaire

Time Frame: Week 2

Dietary information will be collected from the participants using a self-reported food frequency diary questionnaire. The diary will log food, amount eaten, how it was prepared, and brand name of participant food intake at breakfast, lunch, snacks, and dinner.

Fat Mass

Time Frame: Week 2

lbs

Resting Metabolic Rate

Time Frame: Week 2

Fat Free Mass

Time Frame: Week 2

lbs

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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