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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727895
Recruitment Status : Completed
First Posted : November 16, 2012
Results First Posted : July 31, 2014
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):
Radboud University

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

Condition or disease Intervention/treatment Phase
Immunologic Deficiency Syndromes Dietary Supplement: Beta-glucan (Glucan #300®) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
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.
Dietary Supplement: Beta-glucan (Glucan #300®)
No Intervention: Control group

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. • 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 ]
  2. • the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA [ Time Frame: Days 0, 6, 21 ]
  3. • Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways. [ Time Frame: Days 0, 6, 21 ]
  4. • 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 ]
  5. • the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity). [ Time Frame: Days 0, 6, 21 ]
  6. the Composition of Faecal Microbiota [ Time Frame: Days 0, 6, 21 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01727895

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Principal Investigator: Mihai Netea, MD, PhD Radboud University Nijmegen Medical Centre, The Netherlands

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Radboud University Identifier: NCT01727895     History of Changes
Other Study ID Numbers: Betaglucan_immunity
First Posted: November 16, 2012    Key Record Dates
Results First Posted: July 31, 2014
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Radboud University:
Betaglucan, immune modulation, immunoparalysis, immune suppression

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases