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Diet and Fat Mass After Traumatic Spinal Cord Injury

NCT ID: NCT04109586

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2025-12-30

Brief Summary

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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

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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

Conditions

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Obesity Metabolic Disease Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Personalized nutrition therapy

Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury

Group Type EXPERIMENTAL

Personalized nutritional therapy

Intervention Type BEHAVIORAL

Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury

Standard treatment

Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Personalized nutritional therapy

Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vegard Strøm

Head of Research Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vegard Strøm, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnaas Rehabilitation Hospital

Locations

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Sunnaas Rehabilitation Hospital

Nesoddtangen, Bjørnemyr, Norway

Site Status

Countries

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Norway

Other Identifiers

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REK 2017/2443

Identifier Type: -

Identifier Source: org_study_id