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

NCT ID: NCT01727895

Last Updated: 2014-07-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Immunologic Deficiency Syndromes

Keywords

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Betaglucan, immune modulation, immunoparalysis, immune suppression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Beta-glucan (Glucan #300®)

Intervention Type DIETARY_SUPPLEMENT

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Beta-glucan (Glucan #300®)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mihai Netea, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Centre, The Netherlands

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 25268806 (View on PubMed)

Other Identifiers

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Betaglucan_immunity

Identifier Type: -

Identifier Source: org_study_id