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

NCT03518892 | Completed DMC

• 1 other identifier: 7333
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Dietary Habits

Keywords

Resting Metabolic Rate

Outcome Measures

Primary Outcomes (5)

• Percentage of Body fat

  Week 2

• Fat Free Mass

  lbs

  Week 2

• Fat Mass

  lbs

  Week 2

• Resting Metabolic Rate

  Week 2

• Dietary Assessment Using Self-Reported Diary Questionaire

  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.

  Week 2

Study Arms (2)

Spinal Cord Injury Group

Body Composition, Resting Metabolic Rate, and dietary assessment

Diagnostic Test: Resting Metabolic Rate; Diagnostic Test: Body Composition; Behavioral: Dietary Assessment

Healthy Controls

Body Composition, Resting Metabolic Rate, and dietary assessment

Diagnostic Test: Resting Metabolic Rate; Diagnostic Test: Body Composition; Behavioral: Dietary Assessment

Interventions

Resting Metabolic Rate DIAGNOSTIC_TEST

30 minute test to determine daily caloric needs

Healthy Controls; Spinal Cord Injury Group

Body Composition DIAGNOSTIC_TEST

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

Healthy Controls; Spinal Cord Injury Group

Dietary Assessment BEHAVIORAL

Self administered dietary logs

Healthy Controls; Spinal Cord Injury Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spinal Cord Injury subjects and healthy controls across central Pennsylvania.

You may qualify if:

• \. 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Feeding Behavior

Interventions

Basal Metabolism; Body Composition; Nutrition Assessment

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Energy Metabolism; Metabolism; Biochemical Phenomena; Chemical Phenomena; Body Constitution; Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• David Gater, MD, PhD, MS

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 8, 2018
• Study Start: March 19, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)