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Diet and Fat Mass After Traumatic Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109586
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : December 15, 2021
Sponsor:
Collaborators:
University of Oslo
University of Copenhagen
Information provided by (Responsible Party):
Vegard Strøm, Sunnaas Rehabilitation Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Disease Spinal Cord Injuries Behavioral: Personalized nutritional therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Behavioral: Personalized nutritional therapy
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Body weight [ Time Frame: Change from Baseline to 12 months follow-up ]
    Measuring body weight in kilograms (kg)

  2. 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.

  3. 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.

  4. 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).

  5. Change in albumin [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of albumin g/dl

  6. Change in fasting glucose [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of fasting glucose (mmol/L)

  7. Change in Creatinine [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of creatinine umol/L

  8. Change in Lipoprotein A1 [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of Lipoprotein A1 (g/L)

  9. Change in Lipoprotein B [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of Lipoprotein B (g/L)

  10. Change in folic acid [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of folic acid (nmol/L)

  11. Change in vitamin B12 [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of vitamin B12 pmol/L

  12. Change in Ferritin [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of ferritin ug/L

  13. 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

  14. 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

  15. Change in Triglycerides [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of triglycerides mmol/L

  16. 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

  17. 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)

  18. Change in Glycated hemoglobin (HbA1c) [ Time Frame: Change from Baseline to 12 months follow-up ]
    Fasted blood analysis of HbA1c mmol/mol

  19. 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)

  20. 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)

  21. 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.

  22. 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.

  23. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109586


Contacts
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Contact: Hanne B Slettahjell, MSc 004748107330 hannebjorg.slettahjell@sunnaas.no
Contact: Christine Henriksen, Ass.Prof 004799003128 Christine.henriksen@medisin.uio.no

Locations
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Norway
Sunnaas Rehabilitation Hospital Recruiting
Nesoddtangen, Bjørnemyr, Norway, 1453
Contact: Hanne Bjørg Slettahjell, MSc    004748107330    Hannebjorg.slettahjell@sunnaas.no   
Contact: Vegard Strøm, PhD    004790632891    vegard.strom@sunnaas.no   
Sponsors and Collaborators
Sunnaas Rehabilitation Hospital
University of Oslo
University of Copenhagen
Investigators
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Principal Investigator: Vegard Strøm, PhD Sunnaas Rehabilitation Hospital
More Information
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Responsible Party: Vegard Strøm, Head of Research Group, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT04109586    
Other Study ID Numbers: REK 2017/2443
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Obesity
Metabolic Diseases
Wounds and Injuries
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System