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.

Phase 3

Completed

• Conditions: Common Cold; Influenza viral infection; Alternative and Complementary Medicine - Herbal remedies; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620001285943
• Lead Sponsor: RDC Global Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-27
• Study Completion: 2021-08-18
• Last Update Posted: 7 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified