MUST-IS
Research type
Research Study
Full title
Multi-Nutrient Supplementation as a Therapeutic Intervention in Ischaemic Stroke\n\n
IRAS ID
287204
Contact name
Oliver Spooner
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Stroke is a significant cause of morbidity and disability worldwide. As the population ages, the economic impact of stroke is becoming substantial. In the UK, the stroke estimated cost is £26 billion a year. A stroke occurs every 5 min, which is >100,000 strokes in the UK each year. The current treatments available are very limited and 80% of acute stroke patients suffer from persistent impaired activities of daily living (ADL) and compromised quality of life (QoL).The brain function recovery involves creating new neural connections. This neuroplasticity could be supported by specific interventions. Our study aims to explore a new approach which endeavours to support the restoration of lost function. Previous pre-clinical work from our research group and others on different models of acquired brain injury, e.g. traumatic brain injury and ischemic stroke showed that an intervention with a specialised multi-nutrient medical food (Souvenaid®), could improve neurological recovery and protect the nervous tissue after injury. This has led to the design of the present proposal for a feasibility study using Souvenaid in ischaemic stroke. We aim to recruit adult inpatients, suffering from acute ischemic stroke, divided into two groups. One group receives standard NHS care + a daily oral nutritional supplement (ONS), while the other group (control group) will be given standard NHS care. We will explore various outcomes, including changes in activities of daily living (ADL), quality of life (QoL), fatigue, cognition, malnutrition, nutrient status and plasma biomarkers relevant to stroke. The primary aim of this pilot study will be to assess the feasibility of this type of intervention in stroke patients, so that we can subsequently plan a large trial, with a series of focused outcomes which will be informed by this pilot trial.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
23/SW/0006
Date of REC Opinion
1 Feb 2023
REC opinion
Favourable Opinion