Effects of N-Pep-12 dietary supplementation on neurorecovery after ischemic stroke.

Abstract

BACKGROUND:

The aim of the study was to evaluate the effects of N-Pep-12 dietary supplementation on neurorecovery of middle-aged and older adults with cognitive impairment after ischemic stroke, using neuropsychological outcome scales.

METHODS:

This was a pilot randomized-controlled, phase IV, academic clinical trial that aimed to assess the effect and the safety of a single daily dose of oral 90 mg of N-Pep-12 for 90 days in supporting neurorecovery, as compared with a control group, performed on middle-aged and older adults after supratentorial ischemic stroke.

RESULTS:

Study group differences in baseline changes at day 90 for Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale, Color Trails 1 and Symbol Search (number incorrect) were statistically significant (Mann-Whitney U test). For MoCA at day 90, a borderline 'intermediate effect' in favour of N-PEP-12 was observed (dCohen = 0.491, η2 = 0.057, OR = 2.436, p = 0.010). HADS Anxiety and Color Trails 1 at day 90 registered a 'small-to-intermediate' effect in favour of N-PEP-12 (dCohen = 0.424, η2 = 0.043, OR = 2.157, p = 0.026; dCohen = 0.481, η2 = 0.055, OR = 2.3927, p = 0.013, respectively). For symbol search errors, an 'intermediate' effect in favour of the control group was observed (dCohen = 0.501, η2 = 0.059, OR = 2.4811, p = 0.007).

CONCLUSION:

This exploratory clinical trial indicates a signal for the benefit of dietary supplementation with N-Pep-12 for the enhancement of neurorecovery after supratentorial ischemic stroke.

• Authors: Maria Balea, Codruta Birle, Cezara Costin, Julia Marton, Ioana Anamaria Muresanu, Nicoleta Jemna, Livia Livint Popa, Dana Slavoaca, Olivia Verisezan Rosu, Adina Stan, Vitalie Vacaras, Stefan Strilciuc, Dafin F Muresanu
• Journal: Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology (Neurol Sci) Vol. 42 Issue 5 Pg. 2031-2037 (May 2021) ISSN: 1590-3478 [Electronic] Italy
• PMID: 33006057 (Publication Type: Clinical Trial, Phase IV, Journal Article, Randomized Controlled Trial)

Chemical References

• Amino Acids
• N-PEP-12

Topics

• Aged
• Amino Acids
• Brain Ischemia (complications, drug therapy)
• Dietary Supplements
• Humans
• Ischemic Stroke
• Middle Aged
• Stroke (complications, drug therapy)