Diet and Fat Mass After Traumatic Spinal Cord Injury

June 17, 2026 updated by: Vegard Strøm, Sunnaas Rehabilitation Hospital

Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury

This is a randomized clinical controlled trial (RCT) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. The long term goal is to prevent gain of body fat mass and obesity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Traumatic spinal cord injury (SCI) is a devastating injury resulting from critical incidents like falls, sports- and traffic accidents, demanding lifelong specialist health care services. A major challenge is the prevalence of obesity following metabolic alterations after SCI. Obesity hampers independence and mobility and has a negative impact on quality of life. Accumulation of adipose tissue is reported to be higher than in able-bodied, explaining the high risk of cardiometabolic disease in the SCI population. Food intake is the supreme variable in prevention of obesity after SCI, however there is a paucity in studies investigating nutrition as a measure to prevent and reduce comorbidity. Key questions that remains unanswered are how early adipose tissue accumulates, if nutritional manipulations can prevent obesity and how follow-up can help maintain a healthy lifestyle. In the present PhD-study, we use MRI techniques to quantify changes in body composition in a cohort study the first year after SCI, and we employ a randomized controlled trial to test the efficacy of a nutrition intervention during rehabilitation aiming to prevent obesity. Successful results will be implemented in care-programs at our hospital for those with SCI and similar mobility impairments, with the aim of improving nutrition practice throughout the course of treatment

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
    • Bjørnemyr
      • Nesoddtangen, Bjørnemyr, Norway, 1453
        • Sunnaas Rehabilitation Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Traumatic spinal cord injury
  • Levels C1-L2
  • American Spinal Injury Association (ASIA) Impairments Scale (AIS) A-D

Exclusion Criteria:

  • Glasgow Coma Scale score (GCS) equal to or lower than 13
  • Below 18 years of age
  • Medical issues like impaired cognitive function, progressive disorders and co-morbidities.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personalized nutrition therapy
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
Behavioral: Personalized nutritional therapy
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
No Intervention: Standard treatment
Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in fat mass (kg)
Time Frame: Change from Baseline to 12 months follow-up
Bioimpedance analysis (BIA; seca mBCA 525) will be used to assess whole-body composition. Total fat mass (kg) derived from BIA will be used as the primary adiposity outcome. In individuals with spinal cord injury, fluid shifts and changes in fat-free mass can influence BIA estimates; therefore, fat mass will be interpreted together with secondary indices (fat mass index and waist circumference) and body water compartments.
Change from Baseline to 12 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: Change from Baseline to 12 months follow-up
Measuring body weight in kilograms (kg)
Change from Baseline to 12 months follow-up
Independency in activities of daily living (ADLs)
Time Frame: Change from Baseline to 12 months follow-up
Spinal Cord Independence Measure (SCIM) III will be used to assess various activities of daily living (ADLs). SCIM III comprises 19 items divided into 3 subscales (self-care, respiration and sphincter management, and mobility). The total SCIM score range from 0 to 100, with the subscales weighted as follows: self-care: scored 0-20; respiration and sphincter management: scored 0-40; and mobility: scored 0-40. Scores are higher in patients that require less assistance or fewer aids to complete basic ADLs.
Change from Baseline to 12 months follow-up
Change in adipose tissue
Time Frame: Change from Baseline to 12 months follow-up
Magnetic resonance imaging (MRI) scanning will be used to determine body composition by quantification of adipose tissues (visceral adipose tissue volume and abdominal subcutaneous adipose tissue volume) and muscle volumes.
Change from Baseline to 12 months follow-up
Changes in Quality of life (QoL)
Time Frame: Changes from Baseline to 12 months follow-up
International Spinal Cord Society QoL Basic Dataset. The QoL data set consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a Numeric Self-Rating Scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
Changes from Baseline to 12 months follow-up
Change in albumin
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of albumin g/dl
Change from Baseline to 12 months follow-up
Change in fasting glucose
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of fasting glucose (mmol/L)
Change from Baseline to 12 months follow-up
Change in Creatinine
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of creatinine umol/L
Change from Baseline to 12 months follow-up
Change in Lipoprotein A1
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of Lipoprotein A1 (g/L)
Change from Baseline to 12 months follow-up
Change in Lipoprotein B
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of Lipoprotein B (g/L)
Change from Baseline to 12 months follow-up
Change in folic acid
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of folic acid (nmol/L)
Change from Baseline to 12 months follow-up
Change in vitamin B12
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of vitamin B12 pmol/L
Change from Baseline to 12 months follow-up
Change in Ferritin
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of ferritin ug/L
Change from Baseline to 12 months follow-up
Change in C-reactive protein (CRP)
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of C-reactive protein mg/l
Change from Baseline to 12 months follow-up
Change in Cholesterol
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of total cholesterol, high density lipoprotein (HDL) and low density lipoprotein (LDL) mmol/L
Change from Baseline to 12 months follow-up
Change in Triglycerides
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of triglycerides mmol/L
Change from Baseline to 12 months follow-up
Change in C-peptid
Time Frame: Change from Baseline to 12 months follow-up
Blood analysis of insulin c-peptid pmol/L in a fasted state and 2 hours post oral glucose tolerance test
Change from Baseline to 12 months follow-up
Change in vitamin 25-hydroxy-vitamin D₃
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of 25-hydroxy-vitamin D₃ (nmol/L)
Change from Baseline to 12 months follow-up
Change in Glycated hemoglobin (HbA1c)
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of HbA1c mmol/mol
Change from Baseline to 12 months follow-up
Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-α (TNF-α)
Time Frame: Change from Baseline to 12 months follow-up
Fasted blood analysis of Interleukin-6 and -1 Tumor necrosis factor-α (TNF-α) (pg/ml)
Change from Baseline to 12 months follow-up
Change in isoprostanes (biomarkers of oxidative stress)
Time Frame: Change from Baseline to 12 months follow-up
Urine analyses of isoprostanes (ng/mg) (biomarkers of oxidative stress)
Change from Baseline to 12 months follow-up
Change in cardiorespiratory fitness levels ml/kg/min
Time Frame: Change from Baseline to 12 months follow-up
Cardiorespiratory fitness levels will be determined by measuring peak oxygen uptake (VO2peak; ml/kg/min) during maximal exercise testing on a treadmill or ergometry cycle.
Change from Baseline to 12 months follow-up
Change in cardiorespiratory fitness levels liter/min
Time Frame: Change from Baseline to 12 months follow-up
Cardiorespiratory fitness levels will be determined by measuring peak oxygen uptake (VO2peak; liter/min) during maximal exercise testing on a treadmill or ergometry cycle.
Change from Baseline to 12 months follow-up
Change in fasting blood glucose level (mmol/Liter)
Time Frame: Change from Baseline to 12 months follow-up
Standardized oral glucose tolerance test (OGTT) will be used to measure the blood glucose level (mmol/Liter) 2 hours after intake of 75 grams glucose in a fasted state.
Change from Baseline to 12 months follow-up
Change in Fat Mass Index (FMI, kg/m2)
Time Frame: Change from baseline to 12 months follow-up
Fat mass index (FMI) will be calculated as total fat mass (kg) divided by height squared (m²), based on BIA-derived fat mass. FMI will be analysed as a key secondary adiposity index, as it standardizes fat mass for body size and may provide a more stable estimate of adiposity than absolute fat mass in spinal cord injury.
Change from baseline to 12 months follow-up
Change in BIA-estimated visceral adipose tissue
Time Frame: Change from baseline to 12 months follow-up
Visceral adipose tissue (VAT) will be estimated using the manufacturer's proprietary prediction equations implemented in the seca mBCA 525. These values represent model-based estimates calibrated against MRI in able-bodied populations and are interpreted as surrogate indicators of central adiposity rather than direct imaging measures. VAT will be analysed as a secondary adiposity outcome.
Change from baseline to 12 months follow-up
Waist circumference (WC, cm)
Time Frame: Change from baseline to 12 months follow-up
Waist circumference will be measured at the midpoint between the lower rib margin and the iliac crest (approximately 2 cm above the umbilicus) using a standardized protocol. Waist circumference is included as an anthropometric marker of central adiposity.
Change from baseline to 12 months follow-up
Change in Fat-free mass
Time Frame: Change from baseline to 12 months follow-up
Fat-free mass (FFM) derived from BIA will be used to describe changes in lean tissue. In this population, FFM is strongly influenced by extracellular water shifts and will therefore be used as supportive information for interpreting changes in fat mass.
Change from baseline to 12 months follow-up
Body mass index (BMI, kg/m²)
Time Frame: Change from baseline to 12 months follow-up.
Body mass index (kg/m²) will be calculated from weight and height according to standard procedures. BMI is included as an anthropometric indicator of overall adiposity.
Change from baseline to 12 months follow-up.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnaas Rehabilitation Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
University of Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vegard Strøm, PhD, Sunnaas Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REK 2017/2443

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

product manufactured in and exported from the U.S.

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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