Spinal Cord InjuriesNCT03518892
Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury
An observational study of Spinal Cord Injuries and Dietary Habits, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Dietary Habits
- What is being tested?
- Resting Metabolic Rate, Body Composition and Dietary Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Spinal Cord Injury subjects and healthy controls across central Pennsylvania.
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Dietary Habits
- Being tested
- Resting Metabolic Rate, Body Composition, Dietary Assessment
- Keywords
- Resting Metabolic Rate
- Medical subject headings
- Spinal Cord Injuries, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting Metabolic RateDiagnostic test
30 minute test to determine daily caloric needs
Body CompositionDiagnostic test
Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat
Dietary AssessmentBehavioural
Self administered dietary logs
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury Group | Body Composition, Resting Metabolic Rate, and dietary assessment Receives: Diagnostic Test: Resting Metabolic Rate; Diagnostic Test: Body Composition; Behavioral: Dietary Assessment | |
| Healthy Controls | Body Composition, Resting Metabolic Rate, and dietary assessment Receives: Diagnostic Test: Resting Metabolic Rate; Diagnostic Test: Body Composition; Behavioral: Dietary Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Body fat
Measured: Week 2
Fat Free Mass
lbs
Measured: Week 2
Fat Mass
lbs
Measured: Week 2
Resting Metabolic Rate
Measured: 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.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start19 Mar 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Gater, MD, PhD, MS, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518892
- Sponsor's protocol ID
- 7333
- Status last verified
- Dec 2020
- First submitted
- 11 Apr 2018
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03518892
- Acronym / sponsor ID
- 7333
- Conditions
- Spinal Cord Injuries, Dietary Habits
- Keywords
- Resting Metabolic Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury Group | – | Diagnostic Test: Resting Metabolic Rate, Diagnostic Test: Body Composition, Behavioral: Dietary AssessmentBody Composition, Resting Metabolic Rate, and dietary assessment |
| Healthy Controls | – | Diagnostic Test: Resting Metabolic Rate, Diagnostic Test: Body Composition, Behavioral: Dietary AssessmentBody Composition, Resting Metabolic Rate, and dietary assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Spinal Cord Injury subjects and healthy controls across central Pennsylvania.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting Metabolic Rate30 minute test to determine daily caloric needs | Diagnostic test | Healthy Controls, Spinal Cord Injury Group |
| Body CompositionTotal Body DXA scan to determine fat mass, fat-free mass, and percent body fat | Diagnostic test | Healthy Controls, Spinal Cord Injury Group |
| Dietary AssessmentSelf administered dietary logs | Behavioural | Healthy Controls, Spinal Cord Injury Group |
Primary outcome
Percentage of Body fat
Time frame: Week 2
Fat Free Mass
Time frame: Week 2
lbs
Fat Mass
Time frame: Week 2
lbs
Resting Metabolic Rate
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gater, MD, PhD, MS principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Dietary Habits, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Body fat (time frame: Week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.