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

Not Applicable

Completed

• Conditions: Immunologic Deficiency Syndromes

• Registration Number: NCT01727895
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-16
• Study Start: 2013-05
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-07
• Results First Submitted: 2014-07-01
• Results First Submitted QC: 2014-07-01
• Last Update Submitted: 2014-07-01
• Results First Posted: 2014-07-31
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)	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

Name	Time	Method
• 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)	days 0, 6, 21
• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA	Days 0, 6, 21
• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.	Days 0, 6, 21
• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)	Days 0, 6, 21
• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).	Days 0, 6, 21
the Composition of Faecal Microbiota	Days 0, 6, 21

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands