Back to resultsEffects of Orally Administered Beta-glucan on Leukocyte Function in Humans (BG)
Primary Purpose
Immunologic Deficiency Syndromes
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Beta-glucan (Glucan #300®)
Sponsored by
About this trial
This is an interventional basic science trial for Immunologic Deficiency Syndromes focused on measuring Betaglucan, immune modulation, immunoparalysis, immune suppression
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).
Sites / Locations
- Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Beta-glucan
Control group
Arm Description
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.
Outcomes
Primary Outcome Measures
Tumor Necrosis Factor (TNF)-α 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
Secondary Outcome Measures
• 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)
• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA
• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.
• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)
• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).
the Composition of Faecal Microbiota
Full Information
NCT ID
NCT01727895
First Posted
November 12, 2012
Last Updated
July 1, 2014
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01727895
Brief Title
Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans
Acronym
BG
Official Title
Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunologic Deficiency Syndromes
Keywords
Betaglucan, immune modulation, immunoparalysis, immune suppression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beta-glucan
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-glucan (Glucan #300®)
Primary Outcome Measure Information:
Title
Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)
Description
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
Time Frame
up to 21 days
Secondary Outcome Measure Information:
Title
• 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
Title
• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA
Time Frame
Days 0, 6, 21
Title
• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.
Time Frame
Days 0, 6, 21
Title
• 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
Title
• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).
Time Frame
Days 0, 6, 21
Title
the Composition of Faecal Microbiota
Time Frame
Days 0, 6, 21
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihai Netea, MD, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Centre, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
25268806
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.
Results Reference
derived
Learn more about this trial
Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans
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