Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans

Radboud University Medical Center15 enrolled

Overview

The purpose of this study is to test wether orally administered Beta-glucan has systemic effects in humans.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Immunologic Deficiency Syndromes

Interventions

Beta-glucan (Glucan #300®)DIETARY_SUPPLEMENT

Eligibility

Sex: MALEMin age: 18 YearsMax age: 36 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent * Age ≥18 * Healthy males Exclusion Criteria: * 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).

Locations (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Outcomes

Primary Outcomes

Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)

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

Time frame: up to 21 days

Secondary Outcomes

• 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)

Time frame: days 0, 6, 21

• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA

Time frame: Days 0, 6, 21

• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.

Time frame: Days 0, 6, 21

• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)

Time frame: Days 0, 6, 21

• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).

Time frame: Days 0, 6, 21

the Composition of Faecal Microbiota

Time frame: Days 0, 6, 21

Data from ClinicalTrials.gov

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