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

Overview

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

Full Title of Study: “Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2013

Detailed Description

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.

Interventions

  • Dietary Supplement: Beta-glucan (Glucan #300®)

Arms, Groups and Cohorts

  • Experimental: Beta-glucan
    • 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.
  • No Intervention: Control group

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • • 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

Participating in This Clinical Trial

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).

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 36 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Radboud University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mihai Netea, MD, PhD, Principal Investigator, Radboud University Nijmegen Medical Centre, The Netherlands

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