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

INTRODUCTION: 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. ß-Glucans have previously been shown to improve melatonin levels in animal studies. Herein, we examined the effectiveness of Aureobasidium pullulans (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, 2.5-13 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. RESULTS: 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. CONCLUSION: 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.

Beneficial effects of novel aureobasidium pullulans strains produced beta-1,3-1,6 glucans on interleukin-6 and D-dimer levels in COVID-19 patients; results of a randomized multiple-arm pilot clinical study.

OBJECTIVE: In this pilot clinical study, we report the beneficial effects of beta glucans derived from two strains AFO-202 and N-163 of a black yeast Aureobasidium pullulans on the biomarkers for cytokine storm and coagulopathy in COVID-19 patients. METHODS: A total of 24 RT-PCR positive COVID-19 patients were recruited and randomly divided into three groups (Gr): Gr. 1 control (n = 8) - Standard treatment; Gr. 2: Standard treatment + AFO-202 beta glucan (n = 8); and Gr. 3, Standard treatment + combination of AFO-202 and N-163 beta glucans (n = 8) for 30 days. RESULTS: There was no mortality or requirement of ventilation of the subjects in any of the groups. There was a decrease in D-Dimer values (751 ng/ml to 143.89 ng/ml) and IL-6 values (7.395-3.16 pg/ml) in Gr. 1 in 15 days but the levels increased to abnormal levels on day 30 (D-Dimer: 202.5 ng/ml; IL-6 55.37 pg/ml); which steadily decreased up to day 30 in groups 2 (D-dimer: 560.99 ng/dl to 79.615; IL-6: 26.18-3.41 pg/ml) and 3 (D-dimer: 1614 ng/dl to 164.25 ng/dl; IL-6: 6.25-0.5 pg/ml). The same trend was observed with ESR. LCR and LeCR increased while NLR decreased significantly in Gr. 3. CD4 + and CD8 + T cell count showed relatively higher increase in Gr.3. There was no difference in CRP within the groups. CONCLUSION: As these beta glucans are well known food supplements with a track record for safety, larger multi-centric clinical studies are recommended to validate their use as an adjunct in the management of COVID-19 and the ensuing long COVID-19 syndrome.

Beneficial effects of black yeast derived 1-3, 1-6 Beta Glucan-Nichi Glucan in a dyslipidemic individual of Indian origin--a case report.

Dyslipidemia is a major risk factor for the development of cardiovascular diseases and statins are the common drugs used to correct dyslipidemia. Herein, we report a case where the subject was a nondiabetic, dyslipidemia patient on medication with Rosuvastatin. After the intake of Rosuvastatin, his triglycerides decreased to a minimum of 220 mg/dL. In order to augment the action of Rosuvastatin, he was advised to take 1.5 mg of Nichi Glucan food supplement, which is a 1,3-1,6 Beta Glucan derived from the black yeast, Aureobasidium pullulans, daily for 2 months. At the end of 2 months, his triglyceride levels decreased from 523 mg/dL (at start of the study) to 175 mg/dL. His VLDL levels, which were 104.6 mg/dL at the start of the study decreased to 35 mg/dL and the HDL cholesterol levels increased from 27 to 38 mg/dL. This is a first of its kind report on the effect of the black yeast derived 1,3-1,6 Beta Glucans on dyslipidemia not associated with diabetes. Thus supplementation of Nichi Glucan, 1,3- 1,6 Beta Glucan derived from the black yeast along with the routine medications was beneficial to treat dyslipidemia and a larger trial is needed to confirm the effects.

The eighth Asia cancer forum: seeking to advance the outcomes of the UN summit: 'global health as the key to a new paradigm in cancer research'.

To date, the Asia Cancer Forum has focused its efforts on creating a common concept for collaborative efforts in international cancer research with a focus on Asia, where cancer incidence is rising dramatically, and also sharing information and knowledge among cancer specialists about the importance of cancer as a global health agenda issue. The Eighth Asia Cancer Forum was held following the historic outcome of the High-level Meeting of the United Nations General Assembly on the Prevention and Control of Non-communicable Diseases held in New York in September 2011, at which cancer was duly recognized as a global health agenda issue. Despite this significant development, however, the issue of cancer, one of the most intractable of all non-communicable diseases, still faces a variety of challenges if it is to be addressed on the global level. The Eighth Asia Cancer Forum sought to address these various issues, seeking ways to capitalize on the outcomes of the UN Meeting and take global collaborative studies and alliances in the field of cancer further. It was recognized that one of the main challenges for the Asia Cancer Forum is to formulate a proposal that demonstrates how middle-income countries can provide a good level of care using only their own limited medical resources. Given that the Asia Cancer Forum is one of the organizations that can provide assistance in working to further boost awareness about cancer research and the situation relating to cancer in Asian countries, discussion also focused on how to concretize activities in the future.

Human pharmacokinetic prediction of UDP-glucuronosyltransferase substrates with an animal scale-up approach.

The aim of the current study was to evaluate the accuracy of allometric scaling methods for drugs metabolized by UDP-glucuronosyltransferases (UGTs), such as ketoprofen, imipramine, lorazepam, levofloxacin, zidovudine, diclofenac, furosemide, raloxifene, gemfibrozil, mycophenolic acid, indomethacin, and telmisartan. Human plasma clearance (CL) predictions were conducted from preclinical in vivo data by using multiple-species allometry with the rule of exponents and single-species allometric scaling (SSS) of mice, rats, monkeys, or dogs. Distribution volume at a steady state (V(ss)) was predicted by multiple-species allometry or SSS of V(ss). Oral plasma clearance (CL(po)) was calculated under the assumption that F(a) × F(g) was equivalent across species. Each of the results was compared with the observed parameter calculated from the clinical data after intravenous or oral administration. Multiple-species allometry and SSS of mice, rats, and dogs resulted in a similar accuracy of CL and CL(po) predictions. Monkeys tended to provide the most accurate predictions of human CL and CL(po). The ability to predict the half-life, which was determined from CL and V(ss) predictions, was more accurate in SSS of rats and monkeys. The in vivo fraction metabolized by glucuronidation (f(m,UGT)) in bile duct-cannulated monkeys was relatively similar to that of humans compared with other animal species, which likely contributed to the highest accuracy of SSS prediction of monkeys. On the basis of the current results, monkeys would be more reliable than other animal species in predicting human pharmacokinetics and f(m,UGT) for drugs metabolized by UGTs.