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

July 1, 2014 updated by: Radboud University Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
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®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)
Time Frame: 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
up to 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
• 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
days 0, 6, 21
• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA
Time Frame: Days 0, 6, 21
Days 0, 6, 21
• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.
Time Frame: Days 0, 6, 21
Days 0, 6, 21
• 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
Days 0, 6, 21
• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).
Time Frame: Days 0, 6, 21
Days 0, 6, 21
the Composition of Faecal Microbiota
Time Frame: Days 0, 6, 21
Days 0, 6, 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Mihai Netea, MD, PhD, Radboud University Nijmegen Medical Centre, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (ESTIMATE)

November 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Betaglucan_immunity

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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