N/A N=15 Randomized Basic Science

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

Immunologic Deficiency Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT01727895 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs) — 691; 749 pg/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Beta-glucan (Glucan #300®) (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Radboud University Medical Center
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)	691; 749	—
SECONDARY • 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)	—	—
SECONDARY • the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA	—	—
SECONDARY • Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.	—	—
SECONDARY • Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)	—	—
SECONDARY • the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).	—	—
SECONDARY the Composition of Faecal Microbiota	—	—

Summary

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

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01727895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.