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

Completed

• Conditions: Spinal Cord Injuries; Dietary Habits
• Interventions: Diagnostic Test: Resting Metabolic Rate; Diagnostic Test: Body Composition; Behavioral: Dietary Assessment

• Registration Number: NCT03518892
• Lead Sponsor: Milton S. Hershey Medical Center

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 Timeline

• Study Start: 2018-03-19
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-05-08
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. C4-L2 motor complete (AIS A & B) Spinal Cord injury for duration greater than 12 months.

2. <5% change in body in body weight over the past 12 months 5. Fluent in written and spoken English

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Resting Metabolic Rate	Body Composition, Resting Metabolic Rate, and dietary assessment
Healthy Controls	Dietary Assessment	Body Composition, Resting Metabolic Rate, and dietary assessment
Spinal Cord Injury Group	Resting Metabolic Rate	Body Composition, Resting Metabolic Rate, and dietary assessment
Spinal Cord Injury Group	Dietary Assessment	Body Composition, Resting Metabolic Rate, and dietary assessment
Healthy Controls	Body Composition	Body Composition, Resting Metabolic Rate, and dietary assessment
Spinal Cord Injury Group	Body Composition	Body Composition, Resting Metabolic Rate, and dietary assessment

Primary Outcome Measures

Name	Time	Method
Percentage of Body fat	Week 2
Dietary Assessment Using Self-Reported Diary Questionaire	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	Week 2	lbs
Resting Metabolic Rate	Week 2
Fat Free Mass	Week 2	lbs

Trial Locations

Locations (1)

Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States