Effects of orally administered Beta-Glucan on leukocyte function in humans, a pilot study

Effects of orally administered Beta-Glucan on leukocyte function in humans, a pilot study - Effects of oral Beta-Glucan on human leukocytes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37015

Enrollment

Registered

2012-11-15

Start date

2012-12-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune suppression

Interventions

Beta-glucan that is commonly available as a health food supplement derived from bakers yeast (S. cerevisiae) and that has been used in vivo in mice with strong immune modulating properties and no ob

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Written informed consent; - Age >=18; - Healthy male;

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the TNF-a secretion by ex vivo LPS-stimulated peripheral blood mononuclear cells (PBMCs).	—

Secondary

Measure	Time frame
Secondary Objective(s): There are 6 secondary objectives: 1. To determine the production of other cytokines (TNF-, aIL-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 albicans, staphylococcus aureus). 2. To determine the absorbance of orally administered Beta-glucan into the blood compartment, measured by ELISA. 3. To determine the effects of Beta-glucan on changes in phenotype and gene expression caused by mechanisms other than changes in the underlying DNA sequence (epigenetic modifications). 4. To determine the effects of Beta-glucan on transcriptional pathways (by use of microarrays) with focus on inflammatory pathways. 5. To determine the effects of Beta-glucan on the leukocyte capacity to phagocytose and kill the fungal pathogen Candida albicans. 6. To determine the effects of Beta-glucan on faecal microbiota	—

Measure

Time frame

Secondary Objective(s): There are 6 secondary objectives: 1. To determine the production of other cytokines (TNF-, aIL-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 albicans, staphylococcus aureus). 2. To determine the absorbance of orally administered Beta-glucan into the blood compartment, measured by ELISA. 3. To determine the effects of Beta-glucan on changes in phenotype and gene expression caused by mechanisms other than changes in the underlying DNA sequence (epigenetic modifications). 4. To determine the effects of Beta-glucan on transcriptional pathways (by use of microarrays) with focus on inflammatory pathways. 5. To determine the effects of Beta-glucan on the leukocyte capacity to phagocytose and kill the fungal pathogen Candida albicans. 6. To determine the effects of Beta-glucan on faecal microbiota

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)