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

December 11, 2020 updated by: Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Spinal Cord Injury subjects and healthy controls across central Pennsylvania.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spinal Cord Injury Group
Body Composition, Resting Metabolic Rate, and dietary assessment
Diagnostic test: Resting Metabolic Rate
30 minute test to determine daily caloric needs
Diagnostic test: Body Composition
Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat
Behavioral: Dietary Assessment
Self administered dietary logs
Healthy Controls
Body Composition, Resting Metabolic Rate, and dietary assessment
Diagnostic test: Resting Metabolic Rate
30 minute test to determine daily caloric needs
Diagnostic test: Body Composition
Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat
Behavioral: Dietary Assessment
Self administered dietary logs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Body fat
Time Frame: Week 2
Week 2
Fat Free Mass
Time Frame: Week 2
lbs
Week 2
Fat Mass
Time Frame: Week 2
lbs
Week 2
Resting Metabolic Rate
Time Frame: Week 2
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.
Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: David Gater, MD, PhD, MS, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2018

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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