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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01727895
First received: November 12, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • • the absorbance of orally administered Beta-glucan into the blood compartment, measured by ELISA [ Time Frame: Days 0, 6, 21 ] [ Designated as safety issue: No ]
  • • transcriptional pathways (by use of microarrays) with focus on inflammatory pathways. [ Time Frame: Days 0, 6, 21 ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • • the leukocyte capacity to phagocytose and kill the fungal pathogen Candida albicans (antifungal activity). [ Time Frame: Days 0, 6, 21 ] [ Designated as safety issue: No ]
  • the composition of faecal microbiota [ Time Frame: Days 0, 6, 21 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727895

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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01727895     History of Changes
Other Study ID Numbers: Betaglucan_immunity
Study First Received: November 12, 2012
Last Updated: March 4, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014