- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04109586
Diet and Fat Mass After Traumatic Spinal Cord Injury
December 5, 2023 updated by: Vegard Strøm, Sunnaas Rehabilitation Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 three-part started-up PhD-study, we use MRI techniques to quantify accumulation of adipose tissue in a cohort study the first year after SCI, test the efficacy of a nutrition intervention to prevent obesity in a randomized controlled trial, and finally, we will test the feasibility of guided online-support to promote a healthy lifestyle after discharge from in-patient rehabilitation.
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
Enrollment (Estimated)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hanne B Slettahjell, MSc
- Phone Number: 004748107330
- Email: hannebjorg.slettahjell@sunnaas.no
Study Contact Backup
- Name: Christine Henriksen, Ass.Prof
- Phone Number: 004799003128
- Email: Christine.henriksen@medisin.uio.no
Study Locations
-
-
Bjørnemyr
-
Nesoddtangen, Bjørnemyr, Norway, 1453
- Recruiting
- Sunnaas rehabilitation hospital
-
Contact:
- Hanne Bjørg Slettahjell, MSc
- Phone Number: 004748107330
- Email: Hannebjorg.slettahjell@sunnaas.no
-
Contact:
- Vegard Strøm, PhD
- Phone Number: 004790632891
- Email: vegard.strom@sunnaas.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Personalized nutrition therapy
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
|
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
|
No Intervention: Standard treatment
Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fat-free mass
Time Frame: Change from Baseline to 12 months follow-up
|
Bioimpedance Analysis (BIA) will be used to determine body composition by measuring fat-free mass
|
Change from Baseline to 12 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: Change from Baseline to 12 months follow-up
|
Measuring body weight in kilograms (kg)
|
Change from Baseline to 12 months follow-up
|
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.
|
Change from Baseline to 12 months follow-up
|
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.
|
Change from Baseline to 12 months follow-up
|
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).
|
Changes from Baseline to 12 months follow-up
|
Change in albumin
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of albumin g/dl
|
Change from Baseline to 12 months follow-up
|
Change in fasting glucose
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of fasting glucose (mmol/L)
|
Change from Baseline to 12 months follow-up
|
Change in Creatinine
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of creatinine umol/L
|
Change from Baseline to 12 months follow-up
|
Change in Lipoprotein A1
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of Lipoprotein A1 (g/L)
|
Change from Baseline to 12 months follow-up
|
Change in Lipoprotein B
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of Lipoprotein B (g/L)
|
Change from Baseline to 12 months follow-up
|
Change in folic acid
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of folic acid (nmol/L)
|
Change from Baseline to 12 months follow-up
|
Change in vitamin B12
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of vitamin B12 pmol/L
|
Change from Baseline to 12 months follow-up
|
Change in Ferritin
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of ferritin ug/L
|
Change from Baseline to 12 months follow-up
|
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
|
Change from Baseline to 12 months follow-up
|
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
|
Change from Baseline to 12 months follow-up
|
Change in Triglycerides
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of triglycerides mmol/L
|
Change from Baseline to 12 months follow-up
|
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
|
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
|
Fasted blood analysis of 25-hydroxy-vitamin D₃ (nmol/L)
|
Change from Baseline to 12 months follow-up
|
Change in Glycated hemoglobin (HbA1c)
Time Frame: Change from Baseline to 12 months follow-up
|
Fasted blood analysis of HbA1c mmol/mol
|
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
|
Fasted blood analysis of Interleukin-6 and -1 Tumor necrosis factor-α (TNF-α) (pg/ml)
|
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
|
Urine analyses of isoprostanes (ng/mg) (biomarkers of oxidative stress)
|
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
|
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 from Baseline to 12 months follow-up
|
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.
|
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
|
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 from Baseline to 12 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vegard Strøm, PhD, Sunnaas rehabilitation hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2019
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
March 30, 2025
Study Registration Dates
First Submitted
July 3, 2019
First Submitted That Met QC Criteria
September 27, 2019
First Posted (Actual)
September 30, 2019
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK 2017/2443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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