Clinical trial NCT01727895: Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans
Official title: Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunologic Deficiency Syndromes
Keywords: Betaglucan, immune modulation, immunoparalysis, immune suppression
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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 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).

Primary outcomes:
measure: Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)
timeFrame: up to 21 days
Secondary outcomes:
measure: • 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)
timeFrame: days 0, 6, 21
measure: • the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA
timeFrame: Days 0, 6, 21
measure: • Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.
timeFrame: Days 0, 6, 21
measure: • Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)
timeFrame: Days 0, 6, 21
measure: • the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).
timeFrame: Days 0, 6, 21
measure: the Composition of Faecal Microbiota
timeFrame: Days 0, 6, 21
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Nijmegen Medical Centre, The Netherlands
name: Mihai Netea, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leentjens J, Quintin J, Gerretsen J, Kox M, Pickkers P, Netea MG. The effects of orally administered Beta-glucan on innate immune responses in humans, a randomized open-label intervention pilot-study. PLoS One. 2014 Sep 30;9(9):e108794. doi: 10.1371/journal.pone.0108794. eCollection 2014.