ObesityNCT04109586
Diet and Fat Mass After Traumatic Spinal Cord Injury
A study testing Personalized nutritional therapy in people with Obesity and Metabolic Disease, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Metabolic Disease, Spinal Cord Injuries
- What is being tested?
- Personalized nutritional therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- 15 Sep 2019to 30 Dec 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic spinal cord injury
- Levels C1-L2
- American Spinal Injury Association (ASIA) Impairments Scale (AIS) A-D
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity, Metabolic Disease, Spinal Cord Injuries
- Being tested
- Personalized nutritional therapy
- Medical subject headings
- Obesity, Metabolic Diseases, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized nutritional therapyBehavioural
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
| Study group | Role | What they receive |
|---|---|---|
| Personalized nutrition therapy | Experimental | Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury Receives: Behavioral: Personalized nutritional therapy |
| Standard treatment | No intervention | Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat mass (kg)
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.
Measured: Change from Baseline to 12 months follow-up
Secondary outcomes (28)
Change in Fat Mass Index (FMI, kg/m2)
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.
Measured: Change from baseline to 12 months follow-up
Change in BIA-estimated visceral adipose tissue
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.
Measured: Change from baseline to 12 months follow-up
Waist circumference (WC, cm)
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.
Measured: Change from baseline to 12 months follow-up
Change in Fat-free mass
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.
Measured: Change from baseline to 12 months follow-up
Body weight
Measuring body weight in kilograms (kg)
Measured: Change from Baseline to 12 months follow-up
Body mass index (BMI, kg/m²)
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.
Measured: Change from baseline to 12 months follow-up.
Change in adipose tissue
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.
Measured: Change from Baseline to 12 months follow-up
Change in fasting blood glucose level (mmol/Liter)
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.
Measured: Change from Baseline to 12 months follow-up
Change in fasting glucose
Fasted blood analysis of fasting glucose (mmol/L)
Measured: Change from Baseline to 12 months follow-up
Change in Glycated hemoglobin (HbA1c)
Fasted blood analysis of HbA1c mmol/mol
Measured: Change from Baseline to 12 months follow-up
Change in Cholesterol
Fasted blood analysis of total cholesterol, high density lipoprotein (HDL) and low density lipoprotein (LDL) mmol/L
Measured: Change from Baseline to 12 months follow-up
Change in Triglycerides
Fasted blood analysis of triglycerides mmol/L
Measured: Change from Baseline to 12 months follow-up
Changes in Quality of life (QoL)
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).
Measured: Changes from Baseline to 12 months follow-up
Independency in activities of daily living (ADLs)
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.
Measured: Change from Baseline to 12 months follow-up
Change in albumin
Fasted blood analysis of albumin g/dl
Measured: Change from Baseline to 12 months follow-up
Change in Creatinine
Fasted blood analysis of creatinine umol/L
Measured: Change from Baseline to 12 months follow-up
Change in Lipoprotein A1
Fasted blood analysis of Lipoprotein A1 (g/L)
Measured: Change from Baseline to 12 months follow-up
Change in Lipoprotein B
Fasted blood analysis of Lipoprotein B (g/L)
Measured: Change from Baseline to 12 months follow-up
Change in folic acid
Fasted blood analysis of folic acid (nmol/L)
Measured: Change from Baseline to 12 months follow-up
Change in vitamin B12
Fasted blood analysis of vitamin B12 pmol/L
Measured: Change from Baseline to 12 months follow-up
Change in Ferritin
Fasted blood analysis of ferritin ug/L
Measured: Change from Baseline to 12 months follow-up
Change in C-reactive protein (CRP)
Fasted blood analysis of C-reactive protein mg/l
Measured: Change from Baseline to 12 months follow-up
Change in C-peptid
Blood analysis of insulin c-peptid pmol/L in a fasted state and 2 hours post oral glucose tolerance test
Measured: Change from Baseline to 12 months follow-up
Change in vitamin 25-hydroxy-vitamin D₃
Fasted blood analysis of 25-hydroxy-vitamin D₃ (nmol/L)
Measured: Change from Baseline to 12 months follow-up
Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-α (TNF-α)
Fasted blood analysis of Interleukin-6 and -1 Tumor necrosis factor-α (TNF-α) (pg/ml)
Measured: Change from Baseline to 12 months follow-up
Change in isoprostanes (biomarkers of oxidative stress)
Urine analyses of isoprostanes (ng/mg) (biomarkers of oxidative stress)
Measured: Change from Baseline to 12 months follow-up
Change in cardiorespiratory fitness levels ml/kg/min
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.
Measured: Change from Baseline to 12 months follow-up
Change in cardiorespiratory fitness levels liter/min
Cardiorespiratory fitness levels will be determined by measuring peak oxygen uptake (VO2peak; liter/min) during maximal exercise testing on a treadmill or ergometry cycle.
Measured: Change from Baseline to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start15 Sep 2019
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University of Copenhagen
- Responsible party
- Principal investigator, Vegard Strøm, Sunnaas Rehabilitation Hospital
- Investigators
- Vegard Strøm, PhD, Principal investigator, Sunnaas Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109586
- Sponsor's protocol ID
- REK 2017/2443
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slettahjell HB, Strom V, Thoresen M, Strom M, Glott T, Biering-Sorensen F, Henriksen C. Effects of an individualized dietitian-led nutrition intervention on body composition during the first year after traumatic spinal cord injury: A randomized controlled trial. Clin Nutr ESPEN. 2026 Jun;73:103133. doi: 10.1016/j.clnesp.2026.103133. Epub 2026 Mar 20.
PubMed 41866118
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04109586
- Acronym / sponsor ID
- REK 2017/2443
- Conditions
- Obesity, Metabolic Disease, Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, University of Copenhagen
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 30 Sep 2019 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized nutrition therapy | Experimental | Behavioral: Personalized nutritional therapyDietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury |
| Standard treatment | No intervention | –Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Traumatic spinal cord injury
- Levels C1-L2
- American Spinal Injury Association (ASIA) Impairments Scale (AIS) A-D
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Personalized nutritional therapyDietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury | Behavioural | Personalized nutrition therapy |
Primary outcome
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.
28 secondary outcomes
Change in Fat Mass Index (FMI, kg/m2)
Time frame: 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
Waist circumference (WC, cm)
Time frame: Change from baseline to 12 months follow-up
Change in Fat-free mass
Time frame: Change from baseline to 12 months follow-up
Body weight
Time frame: Change from Baseline to 12 months follow-up
Body mass index (BMI, kg/m²)
Time frame: Change from baseline to 12 months follow-up.
Change in adipose tissue
Time frame: 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
Change in fasting glucose
Time frame: Change from Baseline to 12 months follow-up
Change in Glycated hemoglobin (HbA1c)
Time frame: Change from Baseline to 12 months follow-up
Change in Cholesterol
Time frame: Change from Baseline to 12 months follow-up
Change in Triglycerides
Time frame: Change from Baseline to 12 months follow-up
Changes in Quality of life (QoL)
Time frame: Changes from Baseline to 12 months follow-up
Independency in activities of daily living (ADLs)
Time frame: Change from Baseline to 12 months follow-up
Change in albumin
Time frame: Change from Baseline to 12 months follow-up
Change in Creatinine
Time frame: Change from Baseline to 12 months follow-up
Change in Lipoprotein A1
Time frame: Change from Baseline to 12 months follow-up
Change in Lipoprotein B
Time frame: Change from Baseline to 12 months follow-up
Change in folic acid
Time frame: Change from Baseline to 12 months follow-up
Change in vitamin B12
Time frame: Change from Baseline to 12 months follow-up
Change in Ferritin
Time frame: Change from Baseline to 12 months follow-up
Change in C-reactive protein (CRP)
Time frame: Change from Baseline to 12 months follow-up
Change in C-peptid
Time frame: 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
Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-α (TNF-α)
Time frame: 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
Change in cardiorespiratory fitness levels ml/kg/min
Time frame: 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
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 18 Jun 2026.
- Derived from this study: PubMed 41866118Slettahjell HB, Strom V, Thoresen M, Strom M, Glott T, Biering-Sorensen F, Henriksen C. Effects of an individualized dietitian-led nutrition intervention on body composition during the first year after traumatic spinal cord injury: A randomized controlled trial. Clin Nutr ESPEN. 2026 Jun;73:103133. doi: 10.1016/j.clnesp.2026.103133. Epub 2026 Mar 20.
- 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.
Vegard Strøm, PhD principal investigator
Sunnaas Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized nutritional therapy in people with Obesity and Metabolic Disease, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
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 3 inclusion and 3 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 18 Jun 2026. 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 Norway. 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?
Change in fat mass (kg) (time frame: Change from Baseline to 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04109586, which also lists 1 linked publication.
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 18 Jun 2026.