Diet and Fat Mass After Traumatic Spinal Cord Injury
Primary Purpose
Obesity, Metabolic Disease, Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Personalized nutritional therapy
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
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.
Sites / Locations
- Sunnaas Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Personalized nutrition therapy
Standard treatment
Arm Description
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor.
Outcomes
Primary Outcome Measures
Change in fat-free mass
Bioimpedance Analysis (BIA) will be used to determine body composition by measuring fat-free mass
Secondary Outcome Measures
Body weight
Measuring body weight in kilograms (kg)
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.
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.
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).
Change in albumin
Fasted blood analysis of albumin g/dl
Change in fasting glucose
Fasted blood analysis of fasting glucose (mmol/L)
Change in Creatinine
Fasted blood analysis of creatinine umol/L
Change in Lipoprotein A1
Fasted blood analysis of Lipoprotein A1 (g/L)
Change in Lipoprotein B
Fasted blood analysis of Lipoprotein B (g/L)
Change in folic acid
Fasted blood analysis of folic acid (nmol/L)
Change in vitamin B12
Fasted blood analysis of vitamin B12 pmol/L
Change in Ferritin
Fasted blood analysis of ferritin ug/L
Change in C-reactive protein (CRP)
Fasted blood analysis of C-reactive protein mg/l
Change in Cholesterol
Fasted blood analysis of total cholesterol, high density lipoprotein (HDL) and low density lipoprotein (LDL) mmol/L
Change in Triglycerides
Fasted blood analysis of triglycerides mmol/L
Change in C-peptid
Blood analysis of insulin c-peptid pmol/L in a fasted state and 2 hours post oral glucose tolerance test
Change in vitamin 25-hydroxy-vitamin D₃
Fasted blood analysis of 25-hydroxy-vitamin D₃ (nmol/L)
Change in Glycated hemoglobin (HbA1c)
Fasted blood analysis of HbA1c mmol/mol
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)
Change in isoprostanes (biomarkers of oxidative stress)
Urine analyses of isoprostanes (ng/mg) (biomarkers of oxidative stress)
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.
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.
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.
Full Information
NCT ID
NCT04109586
First Posted
July 3, 2019
Last Updated
June 12, 2023
Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Oslo, University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT04109586
Brief Title
Diet and Fat Mass After Traumatic Spinal Cord Injury
Official Title
Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Oslo, University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Disease, Spinal Cord Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalized nutrition therapy
Arm Type
Experimental
Arm Description
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor.
Intervention Type
Behavioral
Intervention Name(s)
Personalized nutritional therapy
Intervention Description
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
Primary Outcome Measure Information:
Title
Change in fat-free mass
Description
Bioimpedance Analysis (BIA) will be used to determine body composition by measuring fat-free mass
Time Frame
Change from Baseline to 12 months follow-up
Secondary Outcome Measure Information:
Title
Body weight
Description
Measuring body weight in kilograms (kg)
Time Frame
Change from Baseline to 12 months follow-up
Title
Independency in activities of daily living (ADLs)
Description
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
Title
Change in adipose tissue
Description
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
Title
Changes in Quality of life (QoL)
Description
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
Title
Change in albumin
Description
Fasted blood analysis of albumin g/dl
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in fasting glucose
Description
Fasted blood analysis of fasting glucose (mmol/L)
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in Creatinine
Description
Fasted blood analysis of creatinine umol/L
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in Lipoprotein A1
Description
Fasted blood analysis of Lipoprotein A1 (g/L)
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in Lipoprotein B
Description
Fasted blood analysis of Lipoprotein B (g/L)
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in folic acid
Description
Fasted blood analysis of folic acid (nmol/L)
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in vitamin B12
Description
Fasted blood analysis of vitamin B12 pmol/L
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in Ferritin
Description
Fasted blood analysis of ferritin ug/L
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in C-reactive protein (CRP)
Description
Fasted blood analysis of C-reactive protein mg/l
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in Cholesterol
Description
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
Title
Change in Triglycerides
Description
Fasted blood analysis of triglycerides mmol/L
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in C-peptid
Description
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
Title
Change in vitamin 25-hydroxy-vitamin D₃
Description
Fasted blood analysis of 25-hydroxy-vitamin D₃ (nmol/L)
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in Glycated hemoglobin (HbA1c)
Description
Fasted blood analysis of HbA1c mmol/mol
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-α (TNF-α)
Description
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
Title
Change in isoprostanes (biomarkers of oxidative stress)
Description
Urine analyses of isoprostanes (ng/mg) (biomarkers of oxidative stress)
Time Frame
Change from Baseline to 12 months follow-up
Title
Change in cardiorespiratory fitness levels ml/kg/min
Description
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
Title
Change in cardiorespiratory fitness levels liter/min
Description
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
Title
Change in fasting blood glucose level (mmol/Liter)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne B Slettahjell, MSc
Phone
004748107330
Email
hannebjorg.slettahjell@sunnaas.no
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Henriksen, Ass.Prof
Phone
004799003128
Email
Christine.henriksen@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Strøm, PhD
Organizational Affiliation
Sunnaas Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnaas Rehabilitation Hospital
City
Nesoddtangen
State/Province
Bjørnemyr
ZIP/Postal Code
1453
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne Bjørg Slettahjell, MSc
Phone
004748107330
Email
Hannebjorg.slettahjell@sunnaas.no
First Name & Middle Initial & Last Name & Degree
Vegard Strøm, PhD
Phone
004790632891
Email
vegard.strom@sunnaas.no
12. IPD Sharing Statement
Plan to Share IPD
No
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Diet and Fat Mass After Traumatic Spinal Cord Injury
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