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
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 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 July 20, 2014