Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)
研究概览
简要总结
The purpose of this study is to test wether orally administered Beta-glucan has systemic effects in humans.
详细描述
The immunostimulatory properties of mushrooms have been recognized for centuries, and "medicinal" mushrooms are still widely used in alternative medicine all over the world. Although a number of fungal components have been implicated in these properties, Beta-glucans have attracted the most attention. However, although Beta-glucans are widely used as a health food supplement, their immunomodulatory effects after administration in humans have not yet been determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Healthy males
排除标准
- •Subjects with a history of allergy or intolerance to Beta-glucan
- •Use of any medication
- •Participation in a drug trial or donation of blood 3 months prior to Beta-glucan administration
- •Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressive agents (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion).
结局指标
主要结局
Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)
时间窗: up to 21 days
The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response
次要结局
- • Production of Other Cytokines (TNF-α, Interleukin (IL)-6, IL-10, IL-1β, IL-17, IL-22, Interferon (IFN)-γ) by Leukocytes ex Vivo Stimulated With Various Stimuli (Including LPS, Pam3Cys, Mycobacterium Tuberculosis, Poly(I:C), Candida, Staph Aureus)(days 0, 6, 21)
- • the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA(Days 0, 6, 21)
- • Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.(Days 0, 6, 21)
- • Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)(Days 0, 6, 21)
- • the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).(Days 0, 6, 21)
- the Composition of Faecal Microbiota(Days 0, 6, 21)