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Completed

NCT Number: NCT01727895

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

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

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Key information

Conditions

Immunologic Deficiency Syndromes Immune System Diseases

Age range

18 year–36 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Beta-glucan (Glucan #300®)

Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. • 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

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

    Time frame: Days 0, 6, 21

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

    Time frame: Days 0, 6, 21

  4. • 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

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

    Time frame: Days 0, 6, 21

  6. the Composition of Faecal Microbiota

    Time frame: Days 0, 6, 21

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: BG

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 16, 2012
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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