NCT05474105Befejeződött
Multi-Nutrient Supplementation as a Therapeutic Intervention in Ischaemic Stroke
Multi-Nutrient Supplementation as a Therapeutic Intervention in Ischaemic Stroke (MUST-IS)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 19.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 24 (tényleges)
- Első benyújtás
- 2022. júl. 21.
- Kezdés
- 2023. ápr. 24.
- Elsődleges befejezés
- 2025. jún. 30.
- Fő szponzor
- Barts & The London NHS Trust
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT05474105
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 24
- 2023. ápr. 24. és az elsődleges befejezés (2025. jún. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
Más betegség
- 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).
Laborértékek
- Chronic renal disease Stage 3b and above (I.e. Glomerular filtration rate (GFR) < 44ml/min)
Egyéb
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Royal London Hospital | London | Egyesült Királyság | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.