Nutritional Treatment for the Amelioration of Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— NUTRA-TBI  

Official title:

Nutritional Treatment for the Amelioration of Traumatic Brain Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04418440
• Other study ID #: 273132
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2022
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Bart Health, Royal London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Brain network connectivity	As measured by resting state EEG	10 months
Secondary	Cognitive function	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).	10 months
Secondary	Plasma phospholipid levels	Plasma phospholipid levels will be measured using thin layer chromatography and/or LC-MS. Batch analysis	10 months
Secondary	Omega-3 index	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.	10 months
Secondary	Neurofilament light levels	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.	10 months
Secondary	Inflammatory markers	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.	10 months
Secondary	C-reactive protein	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	10 months