Ketogenic diet in traumatic brain injury pilot v1
Research type
Research Study
Full title
The ketogenic diet to prevent secondary brain injury in traumatic brain injury patients: an intervention design study
IRAS ID
233612
Contact name
Kate Crewdson
Contact email
Sponsor organisation
North Bristol NHS Trust
Clinicaltrials.gov Identifier
Not applicable , Not applicable
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
In 2013-2014 there were 162,544 admissions following head injury in the UK; 445 head injuries each day. Traumatic brain injury is one of the leading causes of disability and death in people below the age of 44. There is evidence to suggest that secondary brain injury, which occurs immediately after the initial insult and can result in profound neurological deficit, is modifiable. Recent interest has focused on the use of a ketogenic diet to reduce these effects of secondary neurological injury.
'Ketone bodies' are naturally produced by the human body under conditions of starvation. There is evidence from human and animal studies that ketone bodies may help to protect tissues, including the brain, during or shortly after periods of reduced oxygen supply, such as in head injury.
Ketogenic diets have been developed and have been used in children with epilepsy for many years. We aim to investigate whether giving a ketogenic diet to patients admitted to hospital after traumatic brain injury will improve their outcomes. This intervention design study will assess the practicalities and safety of giving a ketogenic diet to these patients through a feeding tube inserted into the patient’s stomach via their nose. We aim to define a feeding regimen which will produce raised a rise in ketone levels in patients' blood.
Adult patients presenting to hospital after traumatic brain injury would be eligible. The study will be conducted at a single site and will recruit 20 participants. The study will last a maximum of 14 days for each participant. The intervention will include the placement of a feeding tube via the nose into the stomach (a part of standard care) with a ketogenic feed (KetoCal 4:1 LQ multifibre) given via this tube for up to 14 days. During this period blood samples will be taken to assess any ill-effects.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0032
Date of REC Opinion
5 Jul 2019
REC opinion
Further Information Favourable Opinion