Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans (BG)
This study is currently recruiting participants.
Verified November 2012 by Radboud University
Sponsor:
Radboud University
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01727895
First received: November 12, 2012
Last updated: May 31, 2013
Last verified: November 2012
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Purpose
The purpose of this study is to test wether orally administered Beta-glucan has systemic effects in humans.
| Condition | Intervention |
|---|---|
|
Immunologic Deficiency Syndromes |
Dietary Supplement: Beta-glucan (Glucan #300®) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans, a Pilot Study |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Tumor necrosis factor (TNF)-α secretion by ex vivo lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs) [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]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) [ Time Frame: days 0, 6, 21 ] [ Designated as safety issue: No ]
- • the absorbance of orally administered Beta-glucan into the blood compartment, measured by ELISA [ Time Frame: Days 0, 6, 21 ] [ Designated as safety issue: No ]
- • transcriptional pathways (by use of microarrays) with focus on inflammatory pathways. [ Time Frame: Days 0, 6, 21 ] [ Designated as safety issue: No ]
- • 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 ] [ Designated as safety issue: No ]
- • the leukocyte capacity to phagocytose and kill the fungal pathogen Candida albicans (antifungal activity). [ Time Frame: Days 0, 6, 21 ] [ Designated as safety issue: No ]
- the composition of faecal microbiota [ Time Frame: Days 0, 6, 21 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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®) |
| No Intervention: Control group |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 36 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727895
Contacts
| Contact: Mihai Netea, MD, PhD | 0031-243611111 | M.Netea@aig.umcn.nl |
| Contact: Jenneke Leentjens, MD | 0031-243668420 | J.Leentjens@aig.umcn.nl |
Locations
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands, 6500 HB | |
| Contact: Jenneke Leentjens, MD 0031-243668420 j.Leentjens@aig.umcn.nl | |
| Sub-Investigator: Jenneke leentjens, MD | |
| Principal Investigator: Mihai Netea, MD, PhD | |
Sponsors and Collaborators
Radboud University
Investigators
| Principal Investigator: | Mihai Netea, MD, PhD | Radboud University Nijmegen Medical Centre, The Netherlands |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01727895 History of Changes |
| Other Study ID Numbers: | Betaglucan_immunity |
| Study First Received: | November 12, 2012 |
| Last Updated: | May 31, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Betaglucan, immune modulation, immunoparalysis, immune suppression |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013