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NCT Number: NCT04109586

Diet and Fat Mass After 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.

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Key information

Conditions

Obesity Body Weight Central Nervous System Diseases Metabolic Disease Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnaas Rehabilitation Hospital

Nesoddtangen, Bjørnemyr, 1453, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized nutritional therapy

Behavioral

Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Body weight

    Time frame: Change from Baseline to 12 months follow-up

    Measuring body weight in kilograms (kg)

  6. 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.

  7. 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.

  8. 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.

  9. Change in fasting glucose

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of fasting glucose (mmol/L)

  10. Change in Glycated hemoglobin (HbA1c)

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of HbA1c mmol/mol

  11. 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

  12. Change in Triglycerides

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of triglycerides mmol/L

  13. 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).

  14. 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.

  15. Change in albumin

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of albumin g/dl

  16. Change in Creatinine

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of creatinine umol/L

  17. Change in Lipoprotein A1

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of Lipoprotein A1 (g/L)

  18. Change in Lipoprotein B

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of Lipoprotein B (g/L)

  19. Change in folic acid

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of folic acid (nmol/L)

  20. Change in vitamin B12

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of vitamin B12 pmol/L

  21. Change in Ferritin

    Time frame: Change from Baseline to 12 months follow-up

    Fasted blood analysis of ferritin ug/L

  22. 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

  23. 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

  24. 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)

  25. 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)

  26. 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)

  27. 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.

  28. 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.

Sponsors and collaborators

Lead sponsor

Sunnaas Rehabilitation Hospital

Other

Collaborators

  • University of Copenhagen
  • University of Oslo

Registry information

Official study title

Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2019
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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