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

This study has been completed.
Information provided by (Responsible Party):
Radboud University Identifier:
First received: November 12, 2012
Last updated: July 1, 2014
Last verified: July 2014
The purpose of this study is to test wether orally administered Beta-glucan has systemic effects in humans.

Condition Intervention
Immunologic Deficiency Syndromes Dietary Supplement: Beta-glucan (Glucan #300®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study

Further study details as provided by Radboud University:

Primary Outcome 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 Outcome 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 ]

Enrollment: 15
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: November 12, 2012
Results First Received: July 1, 2014
Last Updated: July 1, 2014

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

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on June 23, 2017