Clinical trial NCT04109586: Diet and Fat Mass After Traumatic Spinal Cord Injury
Official title: Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Metabolic Disease
Spinal Cord Injuries
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: University of Copenhagen
First posted: 2019-09-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in fat-free mass
timeFrame: Change from Baseline to 12 months follow-up
Secondary outcomes:
measure: Body weight
timeFrame: Change from Baseline to 12 months follow-up
measure: Independency in activities of daily living (ADLs)
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in adipose tissue
timeFrame: Change from Baseline to 12 months follow-up
measure: Changes in Quality of life (QoL)
timeFrame: Changes from Baseline to 12 months follow-up
measure: Change in albumin
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in fasting glucose
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in Creatinine
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in Lipoprotein A1
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in Lipoprotein B
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in folic acid
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in vitamin B12
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in Ferritin
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in C-reactive protein (CRP)
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in Cholesterol
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in Triglycerides
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in C-peptid
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in vitamin 25-hydroxy-vitamin D₃
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in Glycated hemoglobin (HbA1c)
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-α (TNF-α)
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in isoprostanes (biomarkers of oxidative stress)
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in cardiorespiratory fitness levels ml/kg/min
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in cardiorespiratory fitness levels liter/min
timeFrame: Change from Baseline to 12 months follow-up
measure: Change in fasting blood glucose level (mmol/Liter)
timeFrame: Change from Baseline to 12 months follow-up
Other outcomes:
Locations:
city: Nesoddtangen
country: Norway
facility: Sunnaas Rehabilitation Hospital
state: Bjørnemyr
Study officials:
affiliation: Sunnaas Rehabilitation Hospital
name: Vegard Strøm, PhD
role: PRINCIPAL_INVESTIGATOR
References: