We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518892
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Dietary Habits Diagnostic Test: Resting Metabolic Rate Diagnostic Test: Body Composition Behavioral: Dietary Assessment

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Spinal Cord Injury subjects and healthy controls across central Pennsylvania.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518892


Locations
Layout table for location information
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: David Gater, MD, PhD, MS Milton S. Hershey Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03518892    
Other Study ID Numbers: 7333
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Milton S. Hershey Medical Center:
Resting Metabolic Rate
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System