Improvement of sleep and melatonin in children with autism spectrum disorder after β‐1,3/1,6‐glucan consumption: An open‐label prospective pilot clinical study

  • Kadalraja Raghavan
    Department of Paediatric Neurology Kenmax Medical Service Private Limited Madurai India
  • Vidyasagar Devaprasad Dedeepiya
    Mary‐Yoshio Translational Hexagon (MYTH) Nichi‐In Centre for Regenerative Medicine (NCRM) Chennai India
  • Ramesh Shankar Kandaswamy
    Department of Psychiatry Lincolnshire Partnership NHS Foundation Trust Lincoln United Kingdom
  • Mangaleswaran Balamurugan
    Department of Neurosurgery Brain and Spine Hospital Chennai India
  • Nobunao Ikewaki
    Department of Medical Life Science Kyushu University of Health and Welfare Japan
  • Tohru Sonoda
    Department of Immunology Junsei Educational Institute Nobeoka Miyazaki Japan
  • Gene Kurosawa
    Department of Academic Research Support Promotion Facility, Center for Research Promotion and Support Fujita Health University Aichi Japan
  • Masaru Iwasaki
    Centre for Advancing Clinical Research (CACR) School of Medicine, University of Yamanashi Chuo Japan
  • Senthilkumar Preethy
    Fujio‐Eiji Academic Terrain (FEAT) Nichi‐In Centre for Regenerative Medicine (NCRM) Chennai India
  • Samuel JK Abraham
    Mary‐Yoshio Translational Hexagon (MYTH) Nichi‐In Centre for Regenerative Medicine (NCRM) Chennai India

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<jats:title>Abstract</jats:title><jats:sec><jats:title>Introduction</jats:title><jats:p>Poor sleep quality is a major problem in patients with autism spectrum disorder (ASD), and is attributed to low melatonin levels. Melatonin supplementation is recommended; however, its effectiveness varies. β‐Glucans have previously been shown to improve melatonin levels in animal studies. Herein, we examined the effectiveness of <jats:italic>Aureobasidium pullulans</jats:italic> (Nichi Glucan), a species of black yeast that contains beta‐1,3/1,6‐glucan, in a pilot study of children with ASD.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Thirteen children (age, 2.5–13 years) with ASD were recruited for the study. The control group consisted of four patients (Gr. 1), while nine patients were classified into the treatment group (Gr. 2). Gr. 2 received 1 g of Nichi Glucan along with conventional therapy, whereas the Gr. 1 (control) patients received conventional therapy alone for 90 days. Serum melatonin levels and sleep patterns, assessed using a subjective questionnaire, were evaluated before and after treatment.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In Gr. 2, the average serum melatonin level increased from 238.85 ng/L preintervention to 394.72 ng/L postintervention. Eight of nine participants (88%) in Gr. 2 showed improvements in sleep pattern and quality, while no improvement was observed in the participants in Gr. 1.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The consumption of Nichi Glucan for 90 days resulted in visible improvement in sleep quality, sleep pattern, and serum melatonin levels, which was reported for the first time by our study. A larger multicenter study is required to validate our findings.</jats:p></jats:sec>

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