Nutritional Treatment for the Amelioration of Traumatic Brain Injury

NCT04418440 | Completed

• 1 other identifier: 273132
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Feasibility to conduct the protocol as stated

  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.

  10 months

Secondary Outcomes (7)

• Brain network connectivity

  10 months

• Cognitive function

  10 months

• Plasma phospholipid levels

  10 months

• Omega-3 index

  10 months

• Neurofilament light levels

  10 months

Study Arms (2)

Control

NO INTERVENTION

Routine NHS care following traumatic brain injury

Treatment

EXPERIMENTAL

Routine NHS care following traumatic brain injury plus daily dose of test compound (oral nutritional supplement)

Dietary Supplement: Souvenaid oral nutritional supplement (Nutricia)

Interventions

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Bart Health, Royal London Hospital

London, E1 1FR, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Chris Uff

  Barts Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 5, 2020
• Study Start: October 14, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)