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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518892
• Other study ID #: 7333
• Status: Completed
• Start date: March 19, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: December 2020
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

4. <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

Related Conditions & MeSH terms

• Dietary Habits
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Diagnostic Test:
• Resting Metabolic Rate
30 minute test to determine daily caloric needs
• Body Composition
Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat

Behavioral:
• Dietary Assessment
Self administered dietary logs

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Body fat		Week 2
Primary	Fat Free Mass	lbs	Week 2
Primary	Fat Mass	lbs	Week 2
Primary	Resting Metabolic Rate		Week 2
Primary	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