Mohamad Habibullah Nur Nadia, Shahar Suzana, Ismail Munirah, Ibrahim Norhayati, Kamaruddin Mohd Zul Amin, Tang Shirley Gee Hoon, Hamid Mohd Faisal Abdul, Ramasamy Kalavathy
Dietetics Programme, Centre for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Federal Territories Kuala Lumpur, Malaysia.
Dietetics Programme, Centre for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Federal Territories Kuala Lumpur, Malaysia
BMJ Open. 2025 Jan 20;15(1):e084277. doi: 10.1136/bmjopen-2024-084277.
Yeast beta-glucan (YBG) are recognised for enhancing the immune system by activating macrophages, a key defence mechanism. Given the global prevalence and impact of upper respiratory tract infections (URTIs) on productivity and healthcare costs, YBG has shown promise as a potential therapeutic and preventive strategy for recurrent respiratory tract infections. However, little is known regarding the efficacy of YBG at lower dosages in relation to URTI, fatigue, immune response and uncertainties of how they affect the gut microbiota composition.
This 12-week randomised, double-blinded, placebo control, parallel-group clinical trial aims to evaluate the efficacy of YBG 1,3/1,6 on respiratory tract infection, fatigue, immune markers and gut health among adults with moderate stress. The study involves 198 adults aged 18-59 years with moderate stress levels as assessed using Perceived Stress Scale 10 (score 14-26) and Patient Health Questionnaire 9 (score ≥9); and had symptoms of common colds for the past 6 months as assessed using Jackson Cold Scale. These participants will be randomised into three groups, receiving YBG 1,3/1,6 at either 120 mg, 204 mg or a placebo. The outcomes measures include respiratory infection symptoms, fatigue, mood state and quality of life assessed using Wisconsin Upper Respiratory Symptoms Scale, Multidimensional Fatigue Inventory, Profile of Mood State and Short Form 36 Health Survey Questionnaire, respectively. In addition, full blood analysis and assessment of immune, inflammatory and oxidative stress biomarkers will be taken. Secondary outcome includes gut microbiota analysis using stool samples via 16S rRNA sequencing.
The research protocol of the study was reviewed and approved by the Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM/PPI/111/8/JEP-2023-211). The findings will be disseminated to participants, healthcare professionals and researchers via conference presentations and peer-reviewed publications.
ISRCTN48336189.
酵母β-葡聚糖（YBG）因能激活巨噬细胞（一种关键的防御机制）来增强免疫系统而闻名。鉴于上呼吸道感染（URTIs）在全球的流行情况及其对生产力和医疗成本的影响，YBG已显示出作为复发性呼吸道感染潜在治疗和预防策略的前景。然而，关于较低剂量的YBG在治疗URTI、疲劳、免疫反应方面的疗效以及它们如何影响肠道微生物群组成的不确定性，人们知之甚少。
这项为期12周的随机、双盲、安慰剂对照、平行组临床试验旨在评估YBG 1,3/1,6对中度应激成年人的呼吸道感染、疲劳、免疫标志物和肠道健康的疗效。该研究涉及198名年龄在18至59岁之间的成年人，他们使用感知压力量表10（得分14 - 26）和患者健康问卷9（得分≥9）评估为中度应激水平；并且根据杰克逊感冒量表评估，在过去6个月有普通感冒症状。这些参与者将被随机分为三组，分别接受120毫克、204毫克的YBG 1,3/1,6或安慰剂。结局指标包括分别使用威斯康星上呼吸道症状量表、多维疲劳量表、情绪状态量表和简短健康调查问卷36评估的呼吸道感染症状、疲劳、情绪状态和生活质量。此外，还将进行全血分析以及免疫、炎症和氧化应激生物标志物的评估。次要结局包括通过16S rRNA测序对粪便样本进行肠道微生物群分析。
该研究的研究方案已由马来西亚国民大学（UKM/PPI/111/8/JEP - 2023 - 211）研究伦理委员会审查并批准。研究结果将通过会议报告和同行评审出版物传播给参与者、医疗专业人员和研究人员。
ISRCTN48336189。
