NCT04418440

Nutritional Treatment for the Amelioration of Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 1. Usual standard NHS care (control group) 2. 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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Souvenaid oral nutritional supplement (Nutricia)	Daily dose of a commercially available oral nutritional supplement based around the active compound recipe Fortasyn Connect, produced by Nutricia, Danone.

Timeline

• Start date: 2021-10-14
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2020-06-05
• Last updated: 2024-11-29

Locations

1 site across 1 country: United Kingdom