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Title: Improvement of behavioural pattern and alpha-synuclein levels in autism spectrum
disorder after consumption of a beta-glucan food supplement in a randomized, parallel-group
pilot clinical study
Running head: β-Glucan improves behaviour of kids with autism
Authors:
Kadalraja Raghavan
1,2
(drkraghavan27@gmail.com)
Vidyasagar Devaprasad Dedeepiya
3
(dedeepiya_76@yahoo.co.in)
Nobunao Ikewaki
4,5
(nikewaki@phoenix.ac.jp)
Tohru Sonoda
5
(sonoda@phoenix.ac.jp)
Masaru Iwasaki
6
(miwasaki@yamanashi.ac.jp)
Senthilkumar Preethy
7
(drspp@nichimail.jp)
Samuel JK Abraham
3,6,8
(drsam@nichimail.jp)
Affiliations:
1. Department of Paediatric Neurology, Kenmax Medical Service Private Limited,
Madurai, India.
2. Department of Paediatric Neurology, Sarvee Integra Private Limited, Chennai, India.
3. The Mary-Yoshio Translational Hexagon (MYTH), Nichi-In Centre for Regenerative
Medicine (NCRM), Chennai, India.
4. Dept. of Medical Life Science, Kyushu University of Health and Welfare, Japan
5. Institute of Immunology, Junsei Educational Institute, Nobeoka, Miyazaki, Japan
6. Centre for Advancing Clinical Research (CACR), University of Yamanashi - School of
Medicine, Chuo, Japan.
All rights reserved. No reuse allowed without permission.
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
The copyright holder for this preprintthis version posted June 29, 2021. ; https://doi.org/10.1101/2021.06.28.21259619doi: medRxiv preprint
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
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7. The Fujio-Eiji Academic Terrain (FEAT), Nichi-In Centre for Regenerative Medicine
(NCRM), Chennai, India.
8. Antony- Xavier Interdisciplinary Scholastics (AXIS)GN Corporation Co. Ltd., Kofu,
Japan
Corresponding Author Information:
Dr. Samuel JK Abraham,
University of Yamanashi - School of Medicine, Chuo, Japan,
Correspondence Address: 3-8, Wakamatsu, Kofu, Yamanashi 400-0866, Japan.
Email id- drsam@nichimail.jp ; Alternate email id: drspp@nichimail.jp
Phone: +81-55-235-7527
Financial disclosure:
No external funding was received for the study
Non-financial disclosure:
Author Samuel Abraham is a shareholder in GN Corporation, Japan which in turn is a
shareholder in the manufacturing company of the AFO 202 Beta Glucan.
Acknowledgements:
The authors thank
1. Mr. Mohan Ponnusamy & staff of Kenmax for their assistance during the clinical study
and data collection of the manuscript.
2. Mr. Takashi Onaka, Mr. Yasunori Ikeue, Mr. Mitsuru Nagataki (Sophy Inc, Kochi,
Japan), for necessary technical clarifications.
All rights reserved. No reuse allowed without permission.
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
The copyright holder for this preprintthis version posted June 29, 2021. ; https://doi.org/10.1101/2021.06.28.21259619doi: medRxiv preprint
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3. Loyola-ICAM College of Engineering and Technology (LICET) for their support to
our research work.
Ethical approval:
The study was registered in India’s clinical trial registry CTRI, Ref no: CTRI/2020/10/028322.
URL:
http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47623&EncHid=&userName=kenmax.
The study was approved by the Institutional Ethics Committee (IEC) of Saravana
Multispeciality Hospital, Madurai, India on 24th August, 2019.
All rights reserved. No reuse allowed without permission.
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
The copyright holder for this preprintthis version posted June 29, 2021. ; https://doi.org/10.1101/2021.06.28.21259619doi: medRxiv preprint
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Abstract:
Background:
Autism spectrum disorders (ASDs) are a wide range of behavioural disabilities for which there
are no definite interventional modalities available. Remedial therapies remain the only option
but with varying outcomes. We have evaluated the childhood autism rating scale (CARS) and
alpha-synuclein levels in this parallel-group, multiple-arm pilot clinical study after
supplementation with a biological response modifier beta-glucan food supplement (Nichi
Glucan).
Methods:
Six subjects with ASD (n = 6) Gr. 1 underwent conventional treatment comprising remedial
behavioural therapies and L-carnosine 500 mg per day, and 12 subjects (n = 12) Gr. 2
underwent supplementation with the Nichi Glucan 0.5 g twice daily along with the
conventional treatment.
Results:
There was a significant decrease in the CARS score in all of the children of the Nichi Glucan
Gr.2 compared to the control (p-value = 0.034517). Plasma levels of alpha-synuclein were
significantly higher in Gr. 2 (Nichi Glucan) than in the control group Gr. 1 (p-value =
0.091701).
Conclusion:
Improvement of the behavioural pattern CARS score and a correlating alpha-synuclein level,
followed by a safe beta-glucan food supplement, warrants further research on other parameters,
All rights reserved. No reuse allowed without permission.
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
The copyright holder for this preprintthis version posted June 29, 2021. ; https://doi.org/10.1101/2021.06.28.21259619doi: medRxiv preprint
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such as gut-microbiota evaluation, and relevant neuronal biomarkers which is likely to cast
light on novel solutions.
Keywords: Autism spectrum disorders (ASDs); Alpha-synuclein; Childhood autism rating
scale (CARS); beta-glucan; food supplement; Nichi Glucan
All rights reserved. No reuse allowed without permission.
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
The copyright holder for this preprintthis version posted June 29, 2021. ; https://doi.org/10.1101/2021.06.28.21259619doi: medRxiv preprint