Improvement of sleep patterns and serum melatonin levels in children with autism spectrum disorders after consumption of beta-1,3/1,6-glucan in a pilot clinical study

<jats:title>Abstract</jats:title> <jats:p>Study objectives: Poor sleep quality is a major problem that patients with autism spectrum disorders (ASD) face, which is attributed to their low melatonin levels. Melatonin supplementation is recommended, but its effectiveness is varied. Beta-glucans have previously been reported to improve melatonin levels in animal studies. Therefore, 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. Methods Thirteen children (age = 2.5 to 13 years) with ASD were recruited into the study. The control group consisted of four patients (Gr. 1), while nine patients were in the treatment group (Gr. 2). Gr. 2 received 1 g of Nichi Glucan along with conventional therapy, whereas Gr. 1 underwent conventional therapy alone for 90 days. The serum melatonin levels and sleep patterns, assessed using a subjective questionnaire, were evaluated before and after treatment. Results In Gr. 2, the average serum melatonin level increased from 238.85 ng/dl pre-intervention to 394.72 ng/dl post-intervention. Eight out of nine subjects (88%) in Gr. 2 group showed and improvement in their sleep pattern and quality, while this improvement was not observed in the control group. Conclusions Our study is the first in the literature to report that consumption of Nichi Glucan for 90 days showed visible improvement in sleep quality, sleep pattern, and serum melatonin levels. A larger multicentre study is warranted to validate our findings.</jats:p>