Diet and Fat Mass After Traumatic Spinal Cord Injury

Sunnaas Rehabilitation Hospital62 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Obesity Metabolic Disease Spinal Cord Injuries

Interventions

Personalized nutritional therapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, Bjørnemyr, Norway

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Change in Fat-free mass

Data from ClinicalTrials.gov

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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.

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

Body weight

Measuring body weight in kilograms (kg)

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Change in fasting glucose

Fasted blood analysis of fasting glucose (mmol/L)

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

Change in Glycated hemoglobin (HbA1c)

Fasted blood analysis of HbA1c mmol/mol

Time frame: 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

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

Change in Triglycerides

Fasted blood analysis of triglycerides mmol/L

Time frame: 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).

Time frame: 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.

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

Change in albumin

Fasted blood analysis of albumin g/dl

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

Change in Creatinine

Fasted blood analysis of creatinine umol/L

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

Change in Lipoprotein A1

Fasted blood analysis of Lipoprotein A1 (g/L)

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

Change in Lipoprotein B

Fasted blood analysis of Lipoprotein B (g/L)

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

Change in folic acid

Fasted blood analysis of folic acid (nmol/L)

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

Change in vitamin B12

Fasted blood analysis of vitamin B12 pmol/L

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

Change in Ferritin

Fasted blood analysis of ferritin ug/L

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

Change in C-reactive protein (CRP)

Fasted blood analysis of C-reactive protein mg/l

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 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.

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