Multi-Nutrient Supplementation as a Therapeutic Intervention in Ischaemic Stroke

Launched by BARTS & THE LONDON NHS TRUST · Jul 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a special multi-nutrient supplement can help improve recovery for patients who have had an ischemic stroke, which happens when a blood clot stops blood flow to the brain. The goal is to see if this supplement, combined with standard care, can enhance daily activities, quality of life, and brain function for stroke patients. Researchers will recruit adults aged 18 to 80 who have recently experienced an acute ischemic stroke and are able to drink the supplement.

Participants in the trial will be divided into two groups: one will receive the standard care provided by the National Health Service (NHS) along with the nutritional supplement, while the other group will only receive the standard care. Throughout the study, researchers will monitor changes in various aspects such as daily living skills, fatigue, and cognitive function. This trial is important because it aims to assess whether this type of nutritional support can be beneficial, paving the way for larger studies in the future. If you're interested or think you might qualify, be sure to discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Allergies to fish oil/milk/soya
• • Known history of galactosaemia
• • Patients that develop malignant middle cerebral artery (MCA) syndrome
• • Current or previous haemorrhagic stroke including sub-arachnoid haemorrhage
• • Patient with nasogastric (NG) tube
• • Patients with dysphagia (routinely tested) who cannot drink the medical food
• • Known malignancy
• • Known pre-existing neurological disease including multiple sclerosis, Alzheimer's disease, Parkinson's disease, previous strokes
• • Pregnant or breastfeeding
• • Inability to complete the follow-up and/or Investigators uncertainty about the ability to complete the follow-up
• • Chronic renal disease Stage 3b and above (I.e. Glomerular filtration rate (GFR) \< 44ml/min)
• • Ischaemic stroke of other determined aetiology as classified by the TOAST classification (not including stroke caused by arterial dissection).
• • Unable to receive enteral nutrition