NCT01727895

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 31, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

November 12, 2012

Results QC Date

July 1, 2014

Last Update Submit

July 1, 2014

Conditions

Immunologic Deficiency Syndromes

Keywords

Betaglucan, immune modulation, immunoparalysis, immune suppression

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 21 days

Secondary Outcomes (6)

  • • 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)

    days 0, 6, 21

  • • the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA

    Days 0, 6, 21

  • • Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.

    Days 0, 6, 21

  • • Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)

    Days 0, 6, 21

  • • the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).

    Days 0, 6, 21

  • +1 more secondary outcomes

Study Arms (2)

Beta-glucan

EXPERIMENTAL

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®)

Control group

NO INTERVENTION

Interventions

Beta-glucan (Glucan #300®)DIETARY_SUPPLEMENT
Beta-glucan

Eligibility Criteria

Age18 Years - 36 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Age ≥18
  • Healthy males

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25268806DERIVED

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Drs. Jenneke Leentjens
Organization
Radboud UMC
Jenneke.Leentjens@radboudumc.nl
0031-243668420

Study Officials

  • Mihai Netea, MD, PhD

    Radboud University Nijmegen Medical Centre, The Netherlands

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 16, 2012

Study Start

May 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 31, 2014

Results First Posted

July 31, 2014

Record last verified: 2014-07

Locations

NL(1)