PEALut in the Dietary Management of Patients with Acute Ischemic Stroke: A Prospective Randomized Controlled Clinical Trial

Abstract

Acute ischemic stroke (AIS), which represents 87% of all strokes, is caused by reduced blood supply to the brain associated with a prolonged inflammatory process that exacerbates brain damage. The composite containing co-ultramicronized Palmitoylethanolamide and luteolin (PEALut) is known to promote the resolution of neuroinflammation, being a promising nutritional approach to contrast inflammatory processes occurring in AIS. This study included 60 patients affected by acute ischemic stroke and undergoing thrombolysis. PEALut 770 mg was administered to 30 patients, twice daily for 90 days, in addition to the standard therapy. Neurological deficit, independence in activities of daily living, disability and cognitive impairment were investigated. In all patients, the severity of AIS defined by the NIHSS score evolved from moderate to minor (p < 0.0001). Patients’ independence in daily living activities and disability evaluated using BI and mRS showed a significant improvement over time, with a statistically significant difference in favor of PEALut-treated patients (p < 0.002 for BI, p < 0.0001 for mRS), who achieved also a marked improvement of cognitive function evaluated using MMSE and MoCA tests. PEALut proved to be a safe and effective treatment in addition to thrombolysis in the management of patients with acute ischemic stroke.