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

NCT ID: NCT03518892

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-19

Study Completion Date

2020-04-01

Brief Summary

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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

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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

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Spinal Cord Injuries Dietary Habits

Keywords

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Resting Metabolic Rate

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal Cord Injury Group

Body Composition, Resting Metabolic Rate, and dietary assessment

Resting Metabolic Rate

Intervention Type DIAGNOSTIC_TEST

30 minute test to determine daily caloric needs

Body Composition

Intervention Type DIAGNOSTIC_TEST

Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat

Dietary Assessment

Intervention Type BEHAVIORAL

Self administered dietary logs

Healthy Controls

Body Composition, Resting Metabolic Rate, and dietary assessment

Resting Metabolic Rate

Intervention Type DIAGNOSTIC_TEST

30 minute test to determine daily caloric needs

Body Composition

Intervention Type DIAGNOSTIC_TEST

Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat

Dietary Assessment

Intervention Type BEHAVIORAL

Self administered dietary logs

Interventions

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Resting Metabolic Rate

30 minute test to determine daily caloric needs

Intervention Type DIAGNOSTIC_TEST

Body Composition

Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat

Intervention Type DIAGNOSTIC_TEST

Dietary Assessment

Self administered dietary logs

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Gater, MD, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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7333

Identifier Type: -

Identifier Source: org_study_id