NCT05474105Completed
Multi-Nutrient Supplementation as a Therapeutic Intervention in Ischaemic Stroke
Multi-Nutrient Supplementation as a Therapeutic Intervention in Ischaemic Stroke (MUST-IS)
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
Stroke is a significant cause of morbidity and disability worldwide. As the population ages, the economic impact of stroke is becoming substantial. In the United Kingdom, the stroke estimated cost is £26 billion a year. A stroke occurs every 5 minutes, which is \>100,000 strokes in the United Kingdom 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. This study aims to explore a new approach which endeavours to support the restoration of lost function. Previous pre-clinical work from the investigator's 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, 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 this oral nutritional supplement in ischaemic stroke. The investigators aim to recruit adult inpatients, suffering from acute ischemic stroke, divided into two groups. One group receives standard National Health Service (NHS) care + a daily oral nutritional supplement (ONS), while the other group (control group) will be given standard NHS care. The investigators 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 the investigators can subsequently plan a large trial, with a series of focused outcomes which will be informed by this pilot trial.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 21 Jul 2022
- Start date
- 24 Apr 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Barts & The London NHS Trust
- Diseases
- Stroke
- NCT number
- NCT05474105
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 24 Apr 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous haemorrhagic stroke including sub-arachnoid haemorrhage
- Known pre-existing neurological disease including multiple sclerosis, Alzheimer's disease, Parkinson's disease, previous strokes
Other illness
- Allergies to fish oil/milk/soya
- Known history of galactosaemia
- Patients that develop malignant middle cerebral artery (MCA) syndrome
- Known malignancy
- Ischaemic stroke of other determined aetiology as classified by the TOAST classification (not including stroke caused by arterial dissection).
Lab values
- Chronic renal disease Stage 3b and above (I.e. Glomerular filtration rate (GFR) \< 44ml/min)
Other
- Patient with nasogastric (NG) tube
- Patients with dysphagia (routinely tested) who cannot drink the medical food
- Pregnant or breastfeeding
- Inability to complete the follow-up and/or Investigators uncertainty about the ability to complete the follow-up
- Unable to receive enteral nutrition
Who the study is looking for
- Age \>18 and \<80
- Acute ischaemic stroke (within 24 h of onset), including the following subtypes according to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification: large-artery atherosclerosis, cardio-embolism, small-vessel occlusion, stroke of undetermined aetiology OR Acute ischaemic stroke (within 24 h of onset) caused by arterial dissection.
- Pre-morbid (modified Rankin Scale) mRS of ≤2
- National Institutes of Health Stroke Scale (NIHSS) score \>4
- CT ASPECT score of ≥6 on presentation CT
- Expected ability to provide consent
- Ability to drink the ONS product within 7 days of incident stroke
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.