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Completed

NCT Number: NCT03518892

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

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.

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Key information

Conditions

Spinal Cord Injuries Behavior Behavior, Animal Central Nervous System Diseases Dietary Habits Feeding Behavior Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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 5. 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
  • Prisoner

Treatment and study plan

Resting Metabolic Rate

Diagnostic Test

30 minute test to determine daily caloric needs

body composition

Diagnostic Test

Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat

Dietary assessment

Behavioral

Self administered dietary logs

Primary outcomes

  1. Percentage of Body fat

    Time frame: Week 2

  2. Fat Free Mass

    Time frame: Week 2

    lbs

  3. Fat Mass

    Time frame: Week 2

    lbs

  4. Resting Metabolic Rate

    Time frame: Week 2

  5. 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 8, 2018
Registry last updated
Dec 16, 2020

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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