NCT04109586

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

6.3 years

First QC Date

July 3, 2019

Last Update Submit

December 18, 2025

Conditions

ObesityMetabolic DiseaseSpinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

  • Change in fat mass (kg)

    Bioimpedance analysis (BIA; seca mBCA 525) will be used to assess whole-body composition. Total fat mass (kg) derived from BIA will be used as the primary adiposity outcome. In individuals with spinal cord injury, fluid shifts and changes in fat-free mass can influence BIA estimates; therefore, fat mass will be interpreted together with secondary indices (fat mass index and waist circumference) and body water compartments.

    Change from Baseline to 12 months follow-up

Secondary Outcomes (28)

  • Change in Fat Mass Index (FMI, kg/m2)

    Change from baseline to 12 months follow-up

  • Change in BIA-estimated visceral adipose tissue

    Change from baseline to 12 months follow-up

  • Waist circumference (WC, cm)

    Change from baseline to 12 months follow-up

  • Change in Fat-free mass

    Change from baseline to 12 months follow-up

  • Body weight

    Change from Baseline to 12 months follow-up

  • +23 more secondary outcomes

Study Arms (2)

Personalized nutrition therapy

EXPERIMENTAL

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

Behavioral: Personalized nutritional therapy

Standard treatment

NO INTERVENTION

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

Interventions

Personalized nutritional therapyBEHAVIORAL

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

Personalized nutrition therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic spinal cord injury
  • Levels C1-L2
  • American Spinal Injury Association (ASIA) Impairments Scale (AIS) A-D

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, Bjørnemyr, 1453, Norway

Location

Related Publications (1)

  • Slettahjell HB, Strom V, Thoresen M, Strom M, Glott T, Biering-Sorensen F, Henriksen C. Effects of an Individualized Dietitian-Led Nutrition Intervention on Body Composition During the First Year After Traumatic Spinal Cord Injury: A Randomized Controlled Trial. Clin Nutr ESPEN. 2026 Mar 20:103133. doi: 10.1016/j.clnesp.2026.103133. Online ahead of print.

    PMID: 41866118DERIVED

MeSH Terms

Conditions

ObesityMetabolic DiseasesSpinal Cord Injuries

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Vegard Strøm, PhD

    Sunnaas Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Group

Study Record Dates

First Submitted

July 3, 2019

First Posted

September 30, 2019

Study Start

September 15, 2019

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)