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Completed

NCT Number: NCT04418440

Nutritional Treatment for the Amelioration of Traumatic Brain Injury

To test the feasibility of administering a commercially available neurotrophic oral nutritional supplement (ONS) for adult patients with acute traumatic brain injury at the Royal London Hospital.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bart Health, Royal London Hospital

London, E1 1FR, United Kingdom

About this study

The study will be a randomised controlled non-blinded trial of adult patients with acute traumatic brain injury at the Royal London Hospital.

There will be randomisation to one of two non-blinded trial groups:

  • Usual standard NHS care (control group)
  • Usual standard NHS care plus daily oral dose of Souvenaid® ONS

The trial protocol will commence between 3-7 days after admission. The trial timeline provides a summary of intervention and assessments.

The trial will last 12 months. The first 6 months will be the formal trial with two groups and follow up assessments. This will be performed on intention to treat basis. After this initial phase the investigators will provide an opportunity for all participants from either group (control or treatment) to take Souvenaid® ONS for a further 6 months with a clinical follow up appointment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult between 18 yrs and 80 yrs of age
  • Acute traumatic brain injury with confirmed radiological features

Exclusion criteria

  • Allergies to fish oil/milk/soya
  • Medical history of galactosaemia
  • Non-traumatic aetiology to head injury
  • Unable to receive enteral nutrition
  • Craniectomy during admission (loss of integrity of skull convexity)
  • Concurrent active neurological disease
  • Pregnancy or breastfeeding

Treatment and study plan

Souvenaid oral nutritional supplement (Nutricia)

Dietary Supplement

Daily dose of a commercially available oral nutritional supplement based around the active compound recipe Fortasyn Connect, produced by Nutricia, Danone.

Primary outcomes

  1. Feasibility to conduct the protocol as stated

    Time frame: 10 months

    To assess logistical issues which might prevent a fully powered study being carried out using this protocol. The investigators will primarily be looking at retention rate. If there is an attrition rate of over 80% then this protocol will be deemed not feasible.

Secondary outcomes

  1. Brain network connectivity

    Time frame: 10 months

    As measured by resting state EEG

  2. Cognitive function

    Time frame: 10 months

    Changes to cognitive function as measure by CANTAB-TBI cognitive test. This is a validated and widely used clinical tool for cognitive assessment in TBI and assesses cognition using the following battery of tests (range of scores in brackets with lower score being worse performance and higher being better performance): paired associates learning (0-70); reaction time (100-5100); spatial working memory (0-153); multitasking test (0-160); one touch stockings of Cambridge (0-15).

  3. Plasma phospholipid levels

    Time frame: 10 months

    Plasma phospholipid levels will be measured using thin layer chromatography and/or LC-MS. Batch analysis

  4. Omega-3 index

    Time frame: 10 months

    The omega-3 index will be analysed in red blood cells. Therefore, lipids will be extracted from red blood cells, followed by transesterification and quantification using gas chromatography coupled to a flame ionisation detector.

  5. Neurofilament light levels

    Time frame: 10 months

    Plasma or serum neurofilament light levels will be measured using either a commercially available enzyme-linked immunosorbent assay, a commercially available chemi-luminescent assay, or the commercially available SIMOA assay. Combined samples will be run on each plate to account for inter plate variability.

  6. Inflammatory markers

    Time frame: 10 months

    Inflammatory markers such as cytokines will be analysed using either enzyme-linked immunosorbent assays or a multiplex system. Combined samples will be run on each plate to account for inter plate variability.

  7. C-reactive protein

    Time frame: 10 months

    CRP will be measured independently using an enzyme-linked immunosorbent assay. Combined samples will be run on each plate to account for inter plate variability

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Acronym: NUTRA-TBI

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2020
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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