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

Immunologic Deficiency Syndromes Clinical Trial

— BG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727895
• Other study ID #: Betaglucan_immunity
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: July 1, 2014
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 36 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes

Intervention

Dietary Supplement:
• Beta-glucan (Glucan #300®)

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Necrosis Factor (TNF)-a Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)	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	up to 21 days	No
Secondary	• Production of Other Cytokines (TNF-a, Interleukin (IL)-6, IL-10, IL-1ß, IL-17, IL-22, Interferon (IFN)-?) by Leukocytes ex Vivo Stimulated With Various Stimuli (Including LPS, Pam3Cys, Mycobacterium Tuberculosis, Poly(I:C), Candida, Staph Aureus)		days 0, 6, 21	No
Secondary	• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA		Days 0, 6, 21	No
Secondary	• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.		Days 0, 6, 21	No
Secondary	• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)		Days 0, 6, 21	No
Secondary	• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).		Days 0, 6, 21	No
Secondary	the Composition of Faecal Microbiota		Days 0, 6, 21	No