Multi-Nutrient Supplementation as a Therapeutic Intervention in Ischaemic Stroke

NCT05474105 | Completed

• 2 other identifiers: EDGE ID 149423287204
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ischemic Stroke

Keywords

Ischemic stroke; Multi-nutrient; oral nutritional supplement

Outcome Measures

Primary Outcomes (1)

• Feasibility of using an Oral Nutritional Supplement (ONS) in ischemic stroke patients at the Royal London Hospital

  Testing feasibility of using ONS in adult population with ischemic stroke at the Royal London Hospital. Traffic light system to indicate whether or not to progress in the future with a similar study (Red: attrition is \> 80%, do not progress, Amber: 30-80% attrition, learn what prevented participants from continuing, to modify design for a future trial, Green: less than 30% attrition, good setup to continue to future study)

  3 month

Secondary Outcomes (28)

• Feasibility (recruitment rate) of using an Oral Nutritional Supplement (ONS) in ischemic stroke patients at the Royal London Hospital

  Check after recruitment finished (30 participants recruited)

• Feasibility (ONS adherence) of using an Oral Nutritional Supplement (ONS) in ischemic stroke patients at the Royal London Hospital

  Check after recruitment finished (30 participants recruited)

• Oral nutritional supplement adherence

  At the end of the study (at 3 months)

• Quality of Life (QoL)

  Baseline and end of study (at 3 months)

• Degree of disability

  Baseline and end of study (at 3 months)

Study Arms (2)

Oral Nutritional Supplement

EXPERIMENTAL

Daily active oral nutritional supplement (ONS) for 3 months + standard care

Dietary Supplement: Oral nutritional supplement

Control

NO INTERVENTION

Standard care

Interventions

Oral nutritional supplement DIETARY_SUPPLEMENT

Daily drink 125 ml together with meal

Oral Nutritional Supplement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Queen Mary University of London: collaborator
• Nutricia Research: collaborator

Study Sites (1)

Royal London Hospital

London, E11FR, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Oliver Spooner, Dr

  Barts Health NHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 26, 2022
• Study Start: April 24, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)