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

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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.

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Authors and Affiliations

  1. RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania

    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

  2. Department of Neurosciences, Iuliu Hațieganu University of Medicine and Pharmacy, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania

    Maria Balea, Codruta Birle, Cezara Costin, Livia Livint Popa, Dana Slavoaca, Olivia Verisezan Rosu, Adina Stan, Vitalie Vacaras, Stefan Strilciuc & Dafin F. Muresanu

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  1. Maria Balea
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Corresponding author

Correspondence to Dafin F. Muresanu.

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The authors declare that they have no conflict of interest.

Ethics approval

All procedures performed involving human participants were in accordance with the 1964 Helsinki Declaration and its later amendments, recommendations of good clinical practice of the International Conference on Harmonization (2001/20/EEC, CPMP/ICH/135/95). The study was approved on 10/12/2015, by the Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy (8 Babeş Street, 400012 Cluj-Napoca, Romania), reference number 507/10.12.2015, amended 82/24/03/2016, 104/12/02/2018. Amendments were submitted to adapt outcome scales prior to study initiation and to correct minor protocol inconsistencies.

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An informed consent form was obtained from each participant of the study.

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Balea, M., Birle, C., Costin, C. et al. Effects of N-Pep-12 dietary supplementation on neurorecovery after ischemic stroke. Neurol Sci 42, 2031–2037 (2021). https://doi.org/10.1007/s10072-020-04707-9

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