Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Adverse effects on long-term glycemic control
研究概览
简要总结
This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses. Apparently healthy Thai adults (N = 8) aged 18-60 years were recruited into a prospective, single-group study. All participants were assigned to consume 5 mL of longan and lingzhi mushroom syrup daily for 12 weeks. Blood concentrations of fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), BUN (blood urea nitrogen), creatinine (Cr), immunoglobulins (IgG, IgM, IgA, and IgE), and C-reactive protein (CRP) were measured at baseline (week 0), week 4, week 8, and week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy adults at Mae Fah Luang University and Chulalongkorn University
- •aged 18-60 years
- •HbA1c < 7%
排除标准
- •self-reported immunodeficiency diseases, autoimmune diseases, infectious diseases, diabetes, thyroid diseases, cancer, hepatic- and/or renal dysfunction, uncontrollable illnesses and life-threatening diseases
- •being allergic to longan and lingzhi products
- •taking medications, herbs, and diet supplements affecting immune system, inflammatory response, and blood glucose a month before study enrollment
- •pregnant and breastfeeding women
结局指标
主要结局
Adverse effects on long-term glycemic control
时间窗: 12 weeks
Blood concentrations of HbA1C (in %) were measured.
Adverse effects on renal function (1)
时间窗: 12 weeks
Blood concentrations of blood urea nitrogen (in mg/dL) were measured.
Adverse effects on fasting blood glucose
时间窗: 12 weeks
Blood concentrations of fasting blood glucose (in mg/dL) were measured.
Adverse effects on hepatic function (2)
时间窗: 12 weeks
Blood concentrations of alanine aminotransferase (ALT) (in units/L) were measured.
Adverse effects on hepatic function (1)
时间窗: 12 weeks
Blood concentrations of aspatate aminotransferase (AST) (in units/L) were measured.
Adverse effects on hepatic function (3)
时间窗: 12 weeks
Blood concentrations of alkaline phosphatase (ALP) (in units/L) were measured.
Adverse effects on renal function (2)
时间窗: 12 weeks
Blood concentrations of serum creatinine (in mg/dL) were measured.
次要结局
- Effect on immune responses (1)(12 weeks)
- Effect on immune responses (2)(12 weeks)
- Effect on immune responses (4)(12 weeks)
- Effect on immune responses (3)(12 weeks)
- Effect on inflammatory responses(12 weeks)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University