ACTRN12620001285943CompletedPhase 3
Effect of Yeast Beta Glucan (Saccharomyces cerevisiae) compared to a placebo on cold and flu symptoms in an Adult Population – A double blind, randomised controlled trial.
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- RDC Global Pty Ltd.
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •Male and females aged 18-65 years old
- •Able to provide informed consent
- •Agree not to take any beta-glucan supplement or any other supplements (e.g. Echinacea, Vitamin C, zinc) or medications (e.g. Tamiflu, Relenza) aimed at preventing URTIs for the duration of the trial (3 months).
Exclusion Criteria
- •Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, Malignancy, lung conditions or chronic asthma)*
- •Anyone regularly (> 3 times per week) consuming unprocessed food high in beta-glucan or with added beta-glucan (e.g. oats, barley and shiitake mushrooms)
- •Acute sickness experienced in the past 2 months
- •Serious mood disorders or neurological disorders such as MS
- •Active smokers and/or nicotine or drug abuse
- •Chronic alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in active or placebo formula
- •Pregnant or lactating woman
- •People medically prescribed medications that would affect the immune and/or the inflammatory response.
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other related clinical study during the past 1 month
- •People with cognitive damage
- •People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year
- •*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
Investigators
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