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

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

Detailed Description
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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.

Official Title
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Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study

Conditions
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Immunologic Deficiency Syndromes

Intervention / Treatment
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* Dietary Supplement: Beta-glucan (Glucan #300®)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta-glucan<br>Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days. | Dietary Supplement: Beta-glucan (Glucan #300®)<br> <br> |
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Betaglucan, immune modulation, immunoparalysis, immune suppression