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Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study

18 Years
36 Years
Open (Enrolling)
Immunologic Deficiency Syndromes

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Trial Information

Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study

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.

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

- 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).

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Tumor necrosis factor (TNF)-α secretion by ex vivo lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs)

Outcome Description:

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

Outcome Time Frame:

up to 21 days

Safety Issue:


Principal Investigator

Mihai Netea, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University Nijmegen Medical Centre, The Netherlands


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

May 2013

Completion Date:

July 2013

Related Keywords:

  • Immunologic Deficiency Syndromes
  • Betaglucan, immune modulation, immunoparalysis, immune suppression
  • Immunologic Deficiency Syndromes