N/A
Completed N=15
Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans
Immunologic Deficiency Syndromes
Source: ClinicalTrials.gov NCT01727895 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs) — 691; 749 pg/ml
Summary
The purpose of this study is to test wether orally administered Beta-glucan has systemic effects in humans.
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 |
— | — |
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).
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. Informational only — not medical advice.