Diet and Fat Mass After Traumatic Spinal Cord Injury

Not Applicable

Active, not recruiting

• Conditions: Obesity; Metabolic Disease; Spinal Cord Injuries

• Registration Number: NCT04109586
• Lead Sponsor: Sunnaas Rehabilitation Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2019-07-03
• Study Start: 2019-09-15
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in fat-free mass	Change from Baseline to 12 months follow-up	Bioimpedance Analysis (BIA) will be used to determine body composition by measuring fat-free mass

Secondary Outcome Measures

Name	Time	Method
Body weight	Change from Baseline to 12 months follow-up	Measuring body weight in kilograms (kg)
Change in Lipoprotein B	Change from Baseline to 12 months follow-up	Fasted blood analysis of Lipoprotein B (g/L)
Change in Triglycerides	Change from Baseline to 12 months follow-up	Fasted blood analysis of triglycerides mmol/L
Change in Glycated hemoglobin (HbA1c)	Change from Baseline to 12 months follow-up	Fasted blood analysis of HbA1c mmol/mol
Independency in activities of daily living (ADLs)	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.
Changes in Quality of life (QoL)	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).
Change in albumin	Change from Baseline to 12 months follow-up	Fasted blood analysis of albumin g/dl
Change in vitamin B12	Change from Baseline to 12 months follow-up	Fasted blood analysis of vitamin B12 pmol/L
Change in isoprostanes (biomarkers of oxidative stress)	Change from Baseline to 12 months follow-up	Urine analyses of isoprostanes (ng/mg) (biomarkers of oxidative stress)
Change in cardiorespiratory fitness levels liter/min	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 in fasting blood glucose level (mmol/Liter)	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 in adipose tissue	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 in Creatinine	Change from Baseline to 12 months follow-up	Fasted blood analysis of creatinine umol/L
Change in folic acid	Change from Baseline to 12 months follow-up	Fasted blood analysis of folic acid (nmol/L)
Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-α (TNF-α)	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 in fasting glucose	Change from Baseline to 12 months follow-up	Fasted blood analysis of fasting glucose (mmol/L)
Change in Lipoprotein A1	Change from Baseline to 12 months follow-up	Fasted blood analysis of Lipoprotein A1 (g/L)
Change in Ferritin	Change from Baseline to 12 months follow-up	Fasted blood analysis of ferritin ug/L
Change in Cholesterol	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 in vitamin 25-hydroxy-vitamin D₃	Change from Baseline to 12 months follow-up	Fasted blood analysis of 25-hydroxy-vitamin D₃ (nmol/L)
Change in cardiorespiratory fitness levels ml/kg/min	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 in C-reactive protein (CRP)	Change from Baseline to 12 months follow-up	Fasted blood analysis of C-reactive protein mg/l
Change in C-peptid	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

Trial Locations

Locations (1)

Sunnaas Rehabilitation Hospital; 🇳🇴 Nesoddtangen, Bjørnemyr, Norway